Stand alone swage method

ABSTRACT

A semi-automated machine and method for singulating individual surgical needles from an bulk supply and attaching a suture to the surgical needle is described. Each of the surgical needles has a suture receiving opening formed therein for receiving a suture. The machine includes a singulation station having a sliding surface that assists an operator in singulating needles and depositing them in a pair of drop locations for subsequent automatic handling. Indexing conveyors, an articulated robot and a precision conveyor are used with a precise positioning station for orienting each needle for automatic handling. A universal gripper mounted on a rotary indexing device automatically receives each individual needle in a predetermined orientation and conveys the needle for sequential processing from station to station to form the needle-suture assembly. A suture feeding and cutting station automatically cuts an indefinite length of suture material to a definite length suture strand and automatically inserts an end of the definite length suture strand into the suture receiving opening formed in the needle. A swage station is provided for swaging the needle to close the suture receiving opening about the suture to secure said suture thereto and form therefrom a needle and suture assembly. A suture pull-test station test each needle suture bond, and selectively and destructively tests the bond for adjusting the swage dies and for statistical quality control. A final off-load station provides an apparatus for assembling a predetermined number of need-suture assemblies in a bundle for subsequent packaging.

This patent application is a divisional patent application of parentpatent application Ser. No. 08/848,927, filed Apr. 30, 1997, now U.S.Pat. No. 6,012,216.

FIELD OF THE INVENTION

The present invention relates generally to machines for automaticallyswaging needles, such as surgical needles to a suture, and morespecifically, to an apparatus that semi-automatically singulatesunsorted needles and automatically swages them to a suture, tests theneedle-suture bond, and and then bundles the needle suture assembly forsubsequent packaging.

DESCRIPTION OF THE PRIOR ART

This application describes in detail an improvement to a portion of theapparatus disclosed in a series of U.S. Patents, of which U.S. Pat. No.5,438,746 entitled "Needle Threading and Swaging System"; and U.S. Pat.No. 5,473,810 entitled "Needle-Suture Assembly and Packaging System" aretypical. All of these patents are assigned to the assignee of thepresent invention.

The automatic needle and suture threading machine described in the abovereferenced U.S. Patents is a highly automated machine intended for highvolume production and packaging of needles and sutures wherein 20,000 to40,000 needles and sutures are to be produced in a single run.

SUMMARY OF THE INVENTION

The present application describes an improved semi-automatic needlesingulation and swage dial assembly for the swaging of needles tosutures fed and cut to length by the apparatus, together withimprovements in the operation of the apparatus.

The present invention is directed to improvements for a stand aloneswage machine that is particularly adapted to assist in thesemi-automated singulation of surgical needles to enable subsequentautomated handling of the needle, automatic swaging, automatic pulltesting of the combined needle and suture (armed sutures), and bundlingof the armed sutures for future packaging.

It is an object of the present invention to provide a machine which willefficiently handle small batches or production runs on needles and toefficiently handle premium needles and super sharp cutting edge needlesin an efficient manner without blunting the cutting edge of the needle,while bundling the same for future packaging.

It is another object of the present invention to provide a machine whichis flexible in operation and enables quick changeovers betweenproduction lots and which minimizes the number of change parts requiredto migrate from one size needle or suture to another.

It is another object of the present invention to provide a machine whichwill handle odd runs or "doctors' specials" as they are referred to inthe trade, where a particular surgeon expresses a preference for anunusual combination of needle type or size and suture material.

It is an objection of the present invention to provide a needlesingulating apparatus for assisting an operator in singulating needlesfor an automatic swaging machine, wherein the apparatus includes a aneedle sliding surface, a pair of drop openings for receiving thesingulated needles, and means to position the singulated needles in aspaced apart relationship on an indexing conveyor for transport to aprecise positioning apparatus. The precise positioning apparatus thenpositions the needle at a first predetermined position for hand-off toan automatic swaging apparatus.

It is another object of the present invention provides a method andmeans for precise positioning of the needle during the hand-off to aprecision universal gripper than will grip the needle and hold it duringsuture insertion. High precision is necessary in the later stages of thepresent invention, or the sutures can not be automatically inserted intothe needle barrel in the subsequent swage operation.

The position and orientation data must be determined for a wide sizerange of needles, since the curved portion of the needles varies by morethan 100% in one dimension, and over a half inch in the other dimension.These variances must be reduced to an accuracy of 0.001 before hand-offof the needle to the swage operation.

In addition to the accuracy of positioning, a correct orientation mustbe determined. To a convention vision systems the needles appear as arcswith similar ends. However, it is vitally important to determine withthe vision system, which end is the barrel end and which end is thesharp end, or the subsequent swage operation will fail.

It is another object of the present invention to provide a plurality ofuniversal grippers mounted on a rotating swage dial for successivelyreceiving an individual one of a plurality of precisely positionedneedles at a first predetermined location and indexing each of saidindividual successive needles in a predetermined orientation from saidfirst predetermined location through successive locations for sequentialprocessing at subsequent predetermined locations, each of said universalgrippers having a cam follower which cooperates with a cam dial toprovide radial reciprocation of the universal grippers with respect tosaid swage dial in response to rotation of said cam dial. The machineincludes a swage dial and a cam dial mounted for rotation about a commonfirst axis of rotation, with the swage dial supported by and mounted forrotation on a first drive shaft which rotates about this single firstaxis of rotation. This first drive shaft is driven by said firstintermittent drive to provide intermittent advancement of the swagedial.

It is another object of the present invention to provide an automaticstand alone swage apparatus with an improved swage dial having an offset motion for the universal grippers that enables the universalgrippers to place and retrieve needles held in a swage device having aswage die opening formed in a fixed swage die and to provide universalgrippers which are rotated by said swage dial to each of saidpredetermined locations and reciprocated in and out of an operativeposition by said cam dial at each of said plurality of predeterminedlocations while simultaneously being off-set so as to be able to placeand retrieve needles held in a swage device having a swage die openingformed in a fixed swage die.

It is an also an object of the instant invention to provide a standalone swage apparatus with an automatic pull-test system that canautomatically perform minimum pull-testing of the needle-suture assemblyin a cost-effective manner and without manual intervention.

Furthermore, it is an object of the present invention to provide anautomatic swage apparatus in combination with an automatic pull-testsystem, wherein the needle-suture assembly is automatically indexed toan automatic pull-test station after the suture has been cut and swagedto the surgical needle wherein the pull-test apparatus includes a firstgripping means for use in non-destructive testing and a second grippingmeans for use in destructive testing of the needle-suture assembly.

Still another object of the instant invention is to provide an automaticpull-test system that can perform a destructive pull-test of aneedle-suture assembly and retain the maximum pull-test values thereoffor statistical analysis thereof and for statistical process control andthat can provide automatic adjustment of the upstream swaging dies usedto produce the armed needle in accordance with statistical processcontrol values.

Finally, it is an object of this invention to provide a rotating arrayof needle collection buckets that enables collection of a predeterminednumber of needle and suture assemblies (armed sutures) that are bundledby the present machine for subsequent packaging in machines such as thattypified by U.S. Pat. 5,487,212 or the machine described in U.S. Ser.No. 521,831, entitled "Single Suture Automated Packaging Machine", bothof which are assigned to the assignee of the present invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a diagrammatic top view of the needle threading and swagingsystem incorporating a semi-automatic needle sorting and singulatingtable for feeding individual needles to a universal gripper mounted on arotary swage dial, an automatic swaging station, an automatic pull-teststation, and an armed suture off-load and bundling station.

FIG. 2 is a diagrammatic view of an edged needle that is typical of theneedles to be singulated and swaged according to the present invention.

FIGS. 3(a)-3(b) together form a flow diagram illustrating the processfor the needle threading and swaging system of the present invention.

FIG. 4 is an elevation side view of the present invention illustratingan operator station, a control computer, portions of the robotichandling device, and the swage drive of the present invention.

FIG. 5 is a top plan view of the present invention with the operatorsafety guards illustrated in FIG. 4 removed.

FIG. 6 is a detailed elevation side view of the present invention fromthe opposite side as illustrated in FIG. 4, with the operator safetyguards removed.

FIG. 7(a) is a top plan view of the needle singulating station of thepresent invention.

FIG. 7(b) is a partially cross-sectioned elevation view of a portion ofthe needle singulating station illustrated in FIG. 7(a).

FIG. 8 is a state or task diagram of the imaging system used to obtainposition and orientation data of individual needles for the roboticsystem used by the present invention.

FIG. 9(a) is a partially cross sectioned plan view of one of theconveyor "boats" used by the precision conveyor of the presentinvention.

FIG. 9(b) is a partially cross sectioned elevation view of one of theconveyor "boats" used by the precision conveyor of the presentinvention.

FIG. 9(c) is a partially cross sectioned elevation view of one of theconveyor "boats" used by the precision conveyor of the presentinvention, with the jaws thereof in an open position.

FIG. 10 is a partially cross sectioned elevation view of the precisionconveyor of the present invention, illustrating the relativerelationships of the precision conveyor, the precision hand off station,the swage dial and the universal gripper used in the present invention.

FIG. 10(a) is a diagrammatic elevation view of the pre-positioning stopand the precision conveyor of the present invention.

FIG. 11(a) is a partially cross-sectioned plan view of the precisionhand off station of the present invention.

FIG. 11(b) is a partially cross-sectioned elevation view of theprecision hand off station illustrated in FIG. 11(a).

FIG. 12(a) is a plan view of the moveable hard stop used in theprecision hand off station of the present invention.

FIG. 12(b) is a side or elevation view of the moveable hard stopillustrated in FIG. 12(a).

FIG. 12(c) is a side profile of a face cam used in the moveable hardstop assembly.

FIG. 13(a) is an elevation view of a portion the apparatus illustratingthe drive for the cam dial and swage dial of the present invention.

FIG. 13(b) is a side view of the drive for the swage dial illustrated inthe elevation view of FIG. 13(a).

FIG. 14 is a detailed and partially cross section view of the drive forthe swage dial taken along section lines "A"--"A" in FIG. 13(a) whichillustrates a universal gripper ready to reciprocate outwardly toreceive an oriented surgical needle from a precision conveyor.

FIG. 15 is front elevation view of the suture drawing and cutting towerassembly used in the present invention.

FIG. 16(a) is top plan view of the suture tipping assembly used in thesuture drawing and cutting apparatus of the present inventionillustrated in FIG. 15.

FIG. 16(b) is front elevation view of the suture tipping assemblyillustrated in FIG. 16(a) and used in the suture drawing and cuttingapparatus of the present invention.

FIG. 17(a) is a top view of the swage dial assembly 150 comprising aswage dial plate 110 having four universal gripper stations 145a,b,c,dmounted thereon.

FIG. 17(b) is cross-sectional view of the four station swage dialassembly 150 showing two universal grippers 155 in a retracted position.

FIG. 17(c) is cross-sectional view of the four station swage dialassembly 150 showing two universal grippers 155 in an extended position.

FIG. 18(a) is detailed top view of the cam dial assembly 120 having camdial plate 125 with cam follower 165a in a retracted position within camtrack 160a.

FIG. 18(b) is top view of the cam dial plate 125 showing cam follower165a in an extended position within cam track 160a.

FIG. 19 is a top plan view of the swage assembly and off-set assembly ofthe present invention used for swaging the needles for sutureattachment.

FIG. 20 is an enlarged isometric view of a suture gripper assemblyhaving gripper arms shown in their open (dotted lines) and closed(suture gripping) positions.

FIG. 21(a) is top plan view of the universal gripper and slide assemblyused in the present invention, illustrating in dotted lines the variousoperating components thereof.

FIG. 21(b) is partially cross-sectioned side view of the universalgripper and slide assembly illustrated in FIG. 21(a).

FIG. 21(c) is a partially hidden front view of the universal gripperillustrated in FIG. 21(a) illustrating in dotted lines the actuatingmechanism used to open the jaws of the universal gripper.

FIG. 22(a) is front face view of the universal gripper showing asurgical needle about to be placed in the swage dies of the presentinvention.

FIG. 22(b) is front face view of the universal gripper and a surgicalneedle with the universal gripper in a relaxed engagement, with theneedle gripped by the swage dies of the present invention.

FIG. 23 is a top plan view of the needle bundling station of the presentinvention illustrating a plurality of compartments, each of whichreceives a predetermined number of needle and suture assemblies.

FIG. 24 is a partially cross section top view of the needle stripperassembly used in the present invention.

FIG. 25 is an elevation view of a needle bucket for the needle bundlingstation, illustrating radial reciprocation of the needle bucket used inthe present invention.

FIG. 25(a) is a front view of the needle bucket for the apparatusillustrated in the elevation view of FIG. 25.

FIG. 25(b) is a top view of the needle bucket for the apparatusillustrated in the elevation view of FIG. 25.

FIG. 26(a) is a top plan view of the fixed and moveable swage dies ofthe present invention.

FIG. 26(b) is an enlarged view of a portion of the apparatus illustratedin FIG. 26(a) with a needle positioned therein before swaging.

FIG. 26(c) is a top plan view of portions of the suture guides of thepresent invention.

FIG. 27 is a diagrammatic side elevation view of the pull test apparatusof the present invention illustrating a load-cell assembly, the gripperassembly and a pull test assembly, and their relationship to theuniversal gripper.

FIG. 28(a) is a front elevation view of the pull test assemblyillustrating the gripper assembly and the slide block assembly.

FIG. 28(b) is a side elevation view of the pull test assembly of FIG.28(a) illustrating the gripper assembly and the slide block assembly.

FIG. 29(a) is a plan view of the load cell assembly of the presentinvention, illustrating the v-plate needle arm.

FIG. 29(b) is an elevation view of the load cell assembly of the presentinvention, illustrating the v-plate needle arm.

FIG. 30 is a rear elevation view of the pull test assembly illustratedin FIGS. 21(a) and 21(b) illustrating the spring tension assembly usedfor non-destructive pull tests.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

The present invention is directed to improvements in a stand alone swagemachine that is particularly adapted to assist in the semi-automatedsingulation of surgical needles to enable subsequent automated handlingof the needle, automatic swaging, automatic pull testing of the combinedneedle and suture, and bundling for future packaging.

The present application describes improvements in the swaging assemblythat swages needles to sutures, together with improvements in theoperation of the apparatus. The present invention enables the swaging ofneedles in symmetric dies, even when one of the dies is fixed inposition.

This application describes in detail an improvement of a portion of theapparatus disclosed in U.S. Pat. No. 5,473,810 entitled "Needle-SutureAssembly and Packaging System" and U.S. Pat. No. 5,473,854 entitled"Machine for the Automated Packaging of Needles and Attached Sutures andMethod of Utilizing the Packaging Machine," both assigned to theassignee of the present invention. The present invention includes animproved drive train for the swage dial which is similar to the swagedial used in the machine described in the aforesaid patents.

The automatic needle and suture threading machine described in U.S. Pat.No. 5,473,810 is a highly automated machine intended for high volumeproduction and packaging of needles and sutures wherein 20,000 to 40,000needles and sutures are to be produced in a single run.

The machine described in this application is designed to efficientlyhandle small batches or production runs on needles and to efficientlyhandle premium needles and super sharp cutting edge needles in anefficient manner. It is intended to provide flexibility in operation anda quick changeover between production lots and to minimize the number ofchange parts required to migrate from one size needle or suture toanother.

The present invention is also intended to handle odd runs or "doctors'specials" as referred to in the trade, where a particular surgeonexpresses a preference for an unusual combination of needle type or sizeand suture material.

Needle and suture assemblies (armed sutures) are swaged by the presentmachine for subsequent packaging in machines such as that typified byU.S. Pat. No. 5,487,212 or the machine described in U.S. Ser. No.521,831, entitled Single Suture Automated Packaging Machine, both ofwhich are assigned to the assignee of the present invention.

The present invention minimizes the handling of the needle and istherefore particularly adapted for the automated handling of premiumneedles and cutting edge needles such as the needle illustrated in FIG.2.

As illustrated in FIG. 2, the needle 39 includes a ground or cuttingedge portion 40 and is illustrated with an attached suture 42 which hasbeen attached by swaging as indicated at 44. The suture 42 may be of anypredefined length, but is commonly provided in lengths that aremultiples of nine inches (18, 27 and 36 inch suture sizes areparticularly common).

Generally, in the needle threading and swaging system of the presentinvention, parallel operations take place simultaneously at a pluralityof different stations to ensure that approximately forty to sixty(40-60) armed surgical needles are assembled and discharged per minute.For instance, as shown in FIG. 1, a semi-automatic needle sorting andsingulating station 50 assists an operator in sorting and singulatingindividual needles to a pair of translucent indexing conveyors 102,104where the singulated needles are imaged by a vision system, selected bya computer, and transferred from the translucent indexing conveyors102,104 to a precision indexing conveyor 106 by a robotic gripper 108.The precision indexing conveyor conveys precisely oriented surgicalneedles to a precise positioning station 100 to be sequentially receivedby a plurality of grippers mounted on the rotary swage dial 150. Therotary swage dial then rotates counter-clockwise as shown by the arrowin FIG. 1, to index each needle to the automatic swaging station 200where the suture material is cut, inserted into the needle, andautomatically swaged thereto. A suture drawing and cutting station 300pulls, tips, cuts and inserts the suture into the needle to be swaged.The needle is swaged and then, the rotary swage dial 150 rotates toindex the armed suture to the automatic pull-test station 400 where eacharmed needle is pull-tested to ensure that the minimum and/ordestructive pull-test requirements of the medical profession, are met.Finally, the rotary swage dial indexes the pull-tested armed needle tothe off-load station 500 where the surgical needle and suture assembliesare handed off for suture bundling for subsequent packaging at anotherlocation.

FIGS. 3(a) and 3(b) are block diagrams which illustrate the automaticneedle threading and swaging process of the instant invention. Forinstance, at the needle singulating station 50, needles are first loadedonto a flat operator work surface at 10, singulated by the operator, andthen automatically and individually fed at step 11 to one of thetranslucent indexing conveyors 102,104. The needles are imaged at step12 and then evaluated with respect to orientation and position by avision tracking system at step 13, picked up by a robot apparatus atstep 14, transferred to a precision conveyor 106 for positioning by therobot apparatus 108 at step 15, and finally conveyed to a load station100 where the needles are precisely positioned at step 16 andtransferred to a universal gripper located on a rotary swage dial 150for subsequent transfer to the swaging station 200 indicated at step 25.A detailed explanation of the apparatus used to carry out each step willbe explained in further detail hereinbelow.

Simultaneous with the needle sorting process described above withrespect to steps 10 through 25, an automatic suture cutting processtakes place at the suture station 300 as shown in FIGS. 3(a) and 3(b)with respect to steps 18 through 28. Indefinite length suture materialis supplied in various spools and configurations that may carry up to5000 yards of material. This is indicated at step 18 in FIG. 3(a), wherethe suture material is loaded into a payoff assembly. A tension constantfor the suture to be drawn is downloaded as indicated at step 19. Adrawing tower apparatus includes grippers that alternately draw lengthsof the suture material from the spool to enable cutting thereof whichlengths are predetermined at step 20.

While the material is being drawn, it may require extra treatment orprocessing. For instance, as described in detail below, it may bedesirable to heat the suture material under tension at the area whichwill become the suture tip in order to stiffen the material tofacilitate the positioning thereof within the suture receiving openingof a surgical needle. Thus, at step 20, heat may be applied to a portionof suture material. In the preferred embodiment of the invention theheating step is performed upstream of the drawing and cutting apparatusto enable the suture to partially cool and harden before cutting. Atstep 21 of the block diagram of FIG. 3(a), the suture material isclamped and gripped by the servo grippers, and at step 22, the suturestrand is drawn to a predetermined length and positioned for insertionwithin the suture receiving opening of the needle for swaging. As thesuture is positioned for insertion, a second suture clamps the suture ata position which will hold the indefinite length end at step 23, and thesuture is cut at step 24 to separate the suture of predetermined lengthfrom the indefinite length suture.

After a surgical needle is indexed to the swaging station 200 asdescribed above, the universal gripper positions the needle in aprecisely oriented position at the swage die opening formed at the endsof two swaging dies of a swage assembly as indicated as step 26 in FIG.3(b). Simultaneously, the suture strand is drawn along a suture axis toregister a tip thereof for insertion within the suture receiving end ofthe needle. Next, at step 27, the gripper assembly at the drawing towerinserts the tip of the suture strand within a lower funnel guide foraccurate positioning within the suture receiving opening of the needlethat is aligned with the suture drawing axis. At step 28, the swagecylinder is activated to automatically swage the suture to the needle.The universal gripper is actuated to grip the needle, and then retractedon the rotary swage dial as shown as step 29 and indexed to a pull-teststation 400 at step 30 so that minimum pull-testing at step 32 ordestructive pull-testing at step 34 may be performed.

Depending upon the results of the minimum pull-test, the needle andsuture assembly will either be indexed by the rotary swage dial to theoff-load station 500 where the armed needle will be bundled if thepull-test requirements are met (as shown as step 32 in FIG. 3(b)), or,will be discharged at the pull-test station if the needle fails theminimum pull-test (as shown as step 35 in FIG. 3(b)). The destructivepull-test always renders the needle incapable of further processing sothe needle is automatically discharged at the pull-test station 400 asindicated at step 35 in FIG. 3(b). Finally, as shown as step 33 in FIG.3(b), needle and suture assemblies passing the minimum pull test areconveyed to an off-load station 500 where the individual armed suturesare bundled for subsequent packaging and sterilization.

A detailed explanation of the apparatus used to carry out each step inthe suture cutting process will be explained in further detailhereinbelow.

Overview of the Apparatus

FIG. 4 is an elevation view of one side of an apparatus constructedaccording to the teachings of the present invention, and FIG. 5 is a topplan view of the apparatus with the safety guards removed. FIG. 6illustrates the apparatus from the opposite side as FIG. 4. FIGS. 4-6are used in the following descriptive overview of the apparatus. Thisapparatus includes a singulation surface 50 on table 53 to assist anoperator in singulating needles that are deposited to the translucentconveyors 102,104, one of the conveyors 104, being depicted in FIG. 4.The operator work station includes a platform 51 for operator seatingand guard rails 52 for operator safety. Safety guards 54 are alsoprovided around the machine for safety purposes.

Each of the needles singulated by the operator are dropped throughopenings 48,49 by sliding the needle along the singulation surface 50.This step avoids the needle to needle contact inherent in the vibratoryfeed bowls illustrated in U.S. Pat. No. 5,473,810 and thus substantiallyreduces the risk that premium needles or cutting edge needles will beblunted by needle contact. As each needle is dropped, it lands at anintermediate staging location, and at an appropriate interval, aftereach index of the indexing conveyor, the needles is blown by a puff ofair to the translucent indexing conveyor, with needles dropped throughopening 48 being transferred to translucent indexing conveyor 102 andneedles being dropped through opening 49 being transferred totranslucent indexing conveyor 104.

The needles thus transferred are indexed forward to imaging stations101,103 wherein a back light provides a high contrast image of theneedle against a white background for imaging purposes. The indexingconveyors 102,104 are indexed approximately 2 inches at each index. Bylimiting the incremental advancement the image processing is step isenhanced, and problems associated with inertial loads on the needles onconveyors 102,104 are minimized. If the indexing conveyors 102,104 areaccelerated too quickly, the needle will remain in its drop position andnot be advanced forward, and conversely, if the needle is moving on theconveyor, and the conveyor is stopped too quickly, the needle willcontinue to travel after the conveyor is stopped. The present apparatusseeks to avoid either of these situations by minimizing the amount ofindex at each incremental step while still providing enough movement toprovide an adequate supply of needles to the apparatus.

The needle singulating apparatus illustrated provides a single needle ateach drop point which substantially enhances the accuracy of the visionsystem and minimizes needle returns that might otherwise be necessaryfor overlapping or nested needles that were either not imaged, orselected by the computer control means 39 for transfer by the roboticapparatus 108.

The needles deposited on the translucent indexing conveyor 104 areimaged by a vision system 105 and these images are processed by acomputer control means 46 to identify the orientation and X,Y coordinatelocation of the needles. Determining the X,Y coordinates alone is notenough in the needle swaging environment inasmuch as the roboticapparatus needs to determine, in the case of a symmetrically formedcurved needle, which end is the barrel end and which end is the cuttingend in order to properly place the needle for subsequent automatedhandling. After both the orientation and location have been determined,a robotic apparatus 108 picks the needles from the translucent conveyors102,104 and places them on a precision indexing conveyor 106. Theprecision conveyor 106 includes a plurality of "boats" 70 which areparticularly adapted to provide precision positioning of the needle. Therotary swage dial 150 includes a drive motor 140 and first and secondindexing transmissions 142,144 which are used to drive the swage dial ina manner as will be hereinafter explained in detail.

The needles transferred by the robotic apparatus 108 are transferred sothat the butt end of the needle 44 is engaged by gripping jaws on theconveyor boats 70 of the precision conveyor 106. While the butt end islocated and gripped by the robotic apparatus 108, at the point of pickupit may be oriented in either direction of curvature. For particularlysmall needles a fixed post may be provided for the robotic apparatus touse in correcting the orientation of curvature. For larger needles, aneedle plow 111 is used so that the direction of curvature for each ofthe needles is uniform. As illustrated in FIG. 5, the apparatus alsoincludes a prepositioner 107 which is adapted to approximately locatethe butt end of the needle and an moveable hard stop assembly at station100 that precisely registers the butt end of the needle to an accuracyof 0.001 inches.

After the needle has been received at the precise positioning station100, it is gripped by one of the universal grippers located on the swagedial mechanism 150 to be indexed through a plurality of stationsincluding a swage station 200 wherein a suture of definite length is cutfrom a suture spool of indefinite length at station 300 and insertedinto the needle at swage station 200 for permanent assembly thereto.After swaging, the needle is advanced to the pull-test station 400 fortesting of the needle suture bond, and then indexed to a bundlingstation 500 wherein a plurality of buckets are circumferentiallyarranged on a rotating turntable to receive a predefined number ofneedles and sutures in each bundle.

FIG. 6 illustrates the apparatus of the present invention from theopposite side of the machine illustrated in FIG. 4 and includesbreakaway portions to more particularly illustrate portions of theprecision conveyor apparatus and the suture drawing and cutting station300. As illustrated in FIG. 6, a spool of suture material 302 is mountedon a convenient location and the indefinite length suture material 304is fed to the suture drawing station through a pretensioning apparatus306, a tensioning roller 314 having a computer controlled tensionconstant which may be selectively downloaded from the computer controlmeans 46 to match the suture material 304 being handled, and a knotdetector 310 which may be used to provide a knot presence signal to thecontrol computer 46 to reject that length of suture after swaging to aneedle. From the knot detector 310 the suture strand 304a is fed througha tipping station 330 which heats the suture strand to a predeterminedtemperature to assist in tipping and cutting the suture for insertioninto the surgical needle. From the heating and tipping station 330, thesuture material is passed to the bottom of the machine to a turnaroundroller 335 where it is grasped by first and second suture clamps whichadvance the suture material 304a in a hand over hand manner. Asillustrated in FIG. 20, clamp 331 includes a traveling carriage 333which reciprocates up and down frame member 338 by means of a timingbelt which is secured to the carriage at 368. A pneumatic actuator 318includes first and second clamps 365a,365b and first and second grippingsurfaces 366a,366b which clamp the suture material therebetween.

In a first cycle of operation, clamp 331 draws the suture of indefinitelength to a suture insertion point immediately adjacent the swage platesof the swaging station and then dwells while a second suture clampclamps the indefinite suture length below the suture cutter 334(illustrated in FIG. 15). After the second suture clamp has engaged thesuture, the cutter 334 is actuated to cut the suture and the tip end ofthe suture 358, illustrated in FIG. 20 is inserted into the needle asillustrated in FIG. 22(b). The tip end of the suture 358 is positionedbelow a funnel dye formed in suture alignment plates 270,271 whichreciprocate immediately below swage plates 273,374. After the suture tipend 358 has been inserted into the barrel end 44 of needle 39, the swagestation is actuated driving the swage plate 273 against swage plate 274to swage the suture tip 358 in the surgical needle 39.

Semi-Automatic Needle Singulation

The needle singulation apparatus, the operation of the indexingconveyors 102,104, the robotic apparatus 108, the precision conveyor 106and the moveable hard stop will be described with respect to FIGS. 7through 12.

Referring to FIGS. 7(a),(b), the semi-automatic needle singulationapparatus includes a singulation or needle sliding surface 50 on table53 which assists an operator in singulating needles that are depositedon the table surface in bulk. While it is well known that it isdifficult to pick up a needle from a flat surface, it has been foundthat an operator may singulate and slide a needle quickly to a droppoint, such as needle drop points 48 and 49 to provide a singulationfunction. These drop points are openings in the singulation surface 50,which open to horizontal channels 55,56 formed in needle block 57,illustrated in partial cross section in FIG. 7(b). Channels 55,56 opento drop openings 58,59 above the translucent indexing conveyors 102,104.When the operator slides a needle to the drop opening 48, it falls adistance of 0.5" to 1.0" to the staging surface of channel 55immediately under the drop opening 48. It is transferred from thestaging surface to the second opening 58 in channel 55 by a puff of airfrom channel 60. Air channel 60 extends upwardly through the needleblock 57 and opens in both directions, with a first opening aligned withchannel 55, and a second opening aligned with channel 56. As thetranslucent conveyor is indexed, a solenoid opens the air supply to airchannel 60, creating a puff of air in both directions which blows anyneedles on the intermediate staging surfaces through the channels, andout the lower openings 58,59 to the translucent conveyors 102,104. Theneedle block is preferably formed of delrin, although other materialswould be suitable, provided the material is not soft enough to let theneedle points inadvertently dig in. The semi-automatic singulationavoids needle to needle contact inherent in the vibratory feed bowlsillustrated in U.S. Pat. No. 5,473,810 and thus substantially reducesthe risk that premium needles or cutting edge needles will be blunted byneedle to needle contact.

The semi-automatic operator work station includes a platform 51 foroperator seating and guard rails 52 for operator safety. Safety guards54 are also provided around the machine for safety purposes. CRTsupports 61a and 61b are also provided to enable the operator to monitorthe automatic operation of the apparatus through suitable computer CRTdisplays.

As will be hereinafter explained in greater detail, the indexingconveyors are alternately indexed a distance of approximately 2" atevery index, and this alternate operation and the close spacing of dropopenings 48,49 enable an operator to singulate 30 to 60 needles aminute, so that only a single needle is deposited at each incrementaladvance of the indexing conveyors 102, 104.

The needles are then advance by the indexing conveyors to imagingstations 101,103 (FIG. 5) to be imaged by the vision system. The roboticand vision control system will be hereinafter described in greaterdetail with respect to FIG. 8. The individual needles are imaged anddata representing both their x,y position and their orientation isobtained by the vision control system. The orientation data is neededsince the correct end of the needle must be presented when the needle ishanded off for automatic swaging.

As described above, and as illustrated in FIG. 5 and 6, the roboticassembly 108 is located downstream from the needle singulating stationand proximate to both of the translucent indexing conveyors 102, 104 andthe precision conveyor 106. In the preferred embodiment describedherein, the robotic assembly 108 is an Adept® 90604 4 axis robot capableof accomplishing needle transfers at a rate of approximately 40transfers per minute as controlled by the robot's corresponding Adept®CC controller. Each robot is a four-axis SCARA (Selective ComplianceAssembly Robot Arm) robot comprising four Joints capable of a variety ofmotion. Robotic grippers 109 are attached to the quill of the robotassembly 108 and are enabled to provide gripping action by pressuresupplied from an air cylinder (not shown).

Referring now to FIGS. 5 and 10, there is illustrated the precisionconveyor 106 which is driven by drive motor assembly 62 at a ratesufficient to index and transfer one oriented surgical needle at a rateof up to one per second (1 needle/sec) to the automatic swagingapparatus. A similar drive motor assembly is provided for driving theindexing conveyors 102,104. As will be explained in detail below, eachof the drive motor assemblies are interfaced with and operate under thecontrol of the control system 46 to pause the indexing motion to enablethe pick-up and transfer of a needle from the indexing conveyor to theprecision conveyor.

FIGS. 9(a),(b) and (c) illustrate in detail one of the plurality ofengagement boats 70 located on precision conveyor 106 for engagingrespective individual surgical needles 39. Each boat is preferablyprovided with a pair of jaws; one jaw 77 being fixedly mounted, and thesecond jaw 79 being slidable within cavity 72. In operation, a push rod76 is pressed in the direction of the arrow "A" shown in FIG. 9(c) tocompress spring 52 which retracts the position of the movable jaw 79 inthe direction indicated by the arrow "B" to allow for placement ofneedle 39 within the notch 78 of both jaws. Normally, spring 73 isbiased as shown in FIG. 6(b) to maintain movable jaw 79 in its engagedposition for retaining a needle 39 in the notch 74. It should beunderstood that any type of releasable engaging mechanism may beprovided for releasably retaining a needle 39 on conveyor boat 70,provided that each needle be correctly oriented on its respective boatfor subsequent swaging to take place.

Motion of the precision conveyor 106 is also paused periodically at thedesired cycle rate to allow for the transfer of the needles 39 theretofrom the robotic assembly 108. In the preferred embodiment, the controlsystem 46 includes a programmable logic controller (PLC) that is indigital communication with the Adept® robot controllers and the visiontracking system components to control the infeed system.

As shown in FIG. 4, the vision tracking system comprises a cameraassembly 105 having two video cameras 105a,105b, one located overheadeach respective illuminated platform portion, 101 and 103, of theindexing conveyors 102,104. As will be explained in detail below, thevideo images of the needles obtained from each camera 105a,105b arebit-mapped or suitably digitized and transmitted via suitabletransmission or communication lines to the remotely located controlsystem computer 46 where a Vision Control task processes the videoimages and inputs the data to the robotic assembly 108.

Preferably, the conveyors 102 and 104 are translucent and are backlit atthe respective portions 101 and 103 so that a sharp video image may beobtained by the overhead camera assembly for processing. It isunderstood that for descriptive purposes, only two video cameras105a,105b corresponding to the two illuminated platforms 101,103 areshown in FIG. 4 and 5.

The through-put and redundancy designed into this vision system ensuresthat there will be no momentary shortage of needles fed to the swagingstation and that maximum throughput of oriented needles for input to theswaging station is achieved. Furthermore, a robotic assembly ofsufficient speed and precision may, in the future, be able to pick uprandomly deposited needles from a moving conveyor and place themdirectly in an oriented position at the swaging station.

In the preferred embodiment, each camera 105a,105b is mountedapproximately one (1) meter above each backlit indexing conveyor imagingarea 101,103 and utilizes an electrically controlled telephoto lens witha focal distance ranging from 10 mm to 140 mm that may be changed withsuitable adaptors. Suitable lens controllers are used to establishlighting/iris, focus, and field of view for each camera lens, and, areinterfaced with the vision system via an RS-232 link.

A further component of the control system for the needle sorting andinfeed apparatus includes an SCADA Node which is used to oversee anddirect the infeed system. This node interfaces with each of the Adept®controllers via discrete RS-232 links which are used to download datainformation, such as needle parameters, error messages, and statusmessages, to the Adept® controllers. The SCADA node may comprise apersonal computer or such suitable device, running commerciallyavailable FIXDMACS® software. Serial communication is used to exchangethe needle parameters entered at the FIX/DMACS "Adept® Setup" screenduring a needle changeover procedure which is used to inform the infeedsystem of the size and type of needles to be processed. After anoperator enters the needle parameters and initiates a changeover, theFIX/DMACS Node will transmit these parameters to the robot controllers.

The Robotic and Vision Control System

The robotic/vision computer control system of the invention isillustrated in the state or task diagram of FIG. 8. As illustrated, thecomputer control system comprises individual computer software programs,each associated with a particular task to be performed by variousassemblies of the apparatus and executed under the control of the PLC620. As shown in FIG. 8, the software architecture for controlling theneedle sorting apparatus of the instant invention performs eight (8)main tasks: a Robot Control task 650; a Vision Control task 660; aConveyor Indexing Control task 680; a SCADA Node Interface task 695; AControl Panel task 660; a Task Manager 640; a Conveyor Initiation task690; and, a Lens Control task 670. Of these eight tasks mentioned above,the first six are active during steady state operation as will beexplained below. FIG. 8 additionally shows the data flow among the tasksand the signals which initiate the tasks. It is understood that thesoftware language used in the preferred embodiment, is Adept's V/V+language, which supports both vision and robotic control in amultitasking environment. A more detailed description of the followingtasks can be found in U.S. Pat. No. 5,495,420, also assigned to theassignee of the present application, the disclosure of which isincorporated herein by reference thereto.

It should be understood to those skilled in the art that the roboticassembly, controller, and camera vision tracking system requirescalibration and configuration procedures for the system to properlyfunction. For instance, the robotic assembly requires that jointpositions be set and joint limits be configured to ensure that the robotavoids structural damage when enabled. Furthermore, a camera-to-robotcalibration is required so that the vision system may accurately computethe positional coordinates of the needle so that the robot may move tothe pick position. This procedure provides a translation matrix betweenthe camera's field-of-view and the robot base position.

The PLC 620 is responsible for initially powering the robot controllerand the robotic assembly. A robot calibration procedure may be initiatedafter power-up to move the robot joints to known "home" positions tosynchronize the digital encoders of the assembly.

The process of starting the PLC 620, robot controllers, indexingconveyors 102, 104 and precision conveyor 106 is time-critical. From therobot controller perspective, when a ROBOT ENABLE signal 619 is raisedby PLC 620, it begins its normal cycle by executing the Robot ControlTask 650, the Vision Control Task 660, the Conveyor Indexing ControlTask 680, and the Conveyor Initiation Task 690; which initiates themovement of indexing conveyor 102, waits approximately up to two (2)seconds, and then initiates the movement of second indexing conveyor 104as will be described in detail below. Under this scenario, the PLCintegrates the startup of the Indexing Conveyors, and swaging machinewith the raising of the ROBOT ENABLE signal 619. As will be explained infurther detail below, when the ROBOT ENABLE signal goes low, the Adeptrobot halts its standard processing and responds to requests from theSCADA node.

Robot Control Task

There is a single Robot Control task associated with the Adept®controller for the robotic assembly 108, indicated as element 652 inFIG. 8. The control system software for the Robot Control task 652manages the robotic assembly 650 as a resource, reads a FIFO buffer 655of identified needle locations which are produced by and input from theVision Control Task 660, interfaces with the programmable logiccontroller (PLC) 620 and control system 46 for needle placementhandshaking, and, initiates the indexing of the conveyors 102 and 104.

The steady state operation of the Robot Control task 650 for the robotassembly 108 is as follows. First, the robot controller continuouslypolls its input FIFO 655 via data line 693 to obtain positionalcoordinate data for the identified needle locations on a respectivetranslucent indexing conveyor 102 or 104. The data for the needlelocations are provided to the FIFO buffer from the Vision Control task660 via respective data lines 697 as will be explained in further detailbelow. When an acceptable (recognizable) needle position is entered intothe FIFO buffer 655, the robot controller will remove the needleposition from the buffer and direct the robot gripper arm 109 to move tothat location on the conveyor. Next, for each recognized needle, theRobot Control task 650 will signal the robot gripper 109 to close on thebarrel portion 44 of needle 39 and to remove the needle and depart fromthe conveyor to an approach location proximate the precision conveyor106. The robot control task then generates a NEEDLE IN GRIPPER signal607 to the PLC as indicated and waits for a response from the PLC 620.As shown in FIG. 8, when the PLC receives a Robot task generated NEEDLEIN GRIPPER signal 607, the PLC 620 will generate a SAFE TO PLACE signal691 for receipt by robot 108. The purpose of the SAFE TO PLACE signal691 is to inform the robotic assembly 108 that a needle may be placedonto a precision conveyor boat 70 of conveyor 106. As a response to thereceipt of the SAFE TO PLACE signal 691, the Robot Control task 652 willgenerate a DON'T INDEX PRECISION CONVEYOR signal 604 for receipt by thePLC 620 immediately before it places the needle on the precisionconveyor 106. While this signal remains high, for e.g., at a logic "1"state, the Adept® robot 108 will attempt to place a needle onto a boat70 of precision conveyor 106. This involves initiating a load solenoidto open the engagement jaws 77,79 of the precision conveyor engagementboat 70 to allow the placement of the needle therebetween, as will beexplained below. Once the movement of the robot has settled and a needleis placed, the Robot task 650 will generate a NEEDLE PLACE COMPLETEsignal 606 for receipt by the PLC 620 and, the PLC will generate asuitable control signal 609 to enable the engagement jaws of theprecision conveyor engagement boat 70 to engage the needle. In thepreferred embodiment, the dwell time of the NEEDLE PLACE COMPLETE signal606 is approximately 48-64 milliseconds. After activating this signal,the robotic assembly 108 will hold the needle in place for the same timeperiod. (48-64 msec.) Immediately thereafter, the robot will open itsgrippers and move back to its approach location away from the engagementboat 70. Finally, the DON'T INDEX PRECISION CONVEYOR signal 604 isremoved indicating that it is now clear for the precision conveyor 106to index which is performed at the command of the PLC 620.

As a safety interlock for conveyor index initiation, the Robot ControlTask 650 will signal the Conveyor Indexing Control Task 680 with aninternal control respective LAST PICK signals 692,696 indicating thatthe robot assembly 108 has picked up the last needle from the currentconveyor as indicated in FIG. 8. If the maximum number of needlesexpected per current camera field-of-view (hereinafter "FOV") is notpicked from the respective current infeed conveyor 102, 104, the RobotControl Task 650 will request the Conveyor Control task 680 to indexthat conveyor belt "early" via the INDEX CONVEYOR 1 EARLY or the INDEXCONVEYOR 2 EARLY signals 611,612 as shown in FIG. 8. Since all signalsaffecting the motion of the conveyors are routed through the ConveyorControl task 680, this task will generate a corresponding INDEX CONVEYOR1 EARLY, signal 211 or INDEX CONVEYOR 2 EARLY, signal 212, for receiptby the Adept® robot. If during normal operation the Robot Control Taskreceives either Index Conveyor 1 Early or the Index Conveyor 2 Earlysignal, it will flush the contents of its FIFO buffer 655 and continueas if the last needle has been picked from the conveyor.

The control software must take into account the floating 16-32 msduration of a digital output based on the time slicing of V/V+. Thiswill affect the calculation for minimum time required for placement inconjunction with setting and resetting the Don't Index Precisionconveyor signal 604.

The Robot Control Task 650 performs error recovery on two type oferrors. These errors are grouped as indexing errors and gross errors. Asin all other tasks, gross errors cause the Task Manager 623 errorrecovery to respond and stop the Robot Control Task immediately. Anindexing error occurs if the robot is waiting for a needle to be placedin its parts FIFO and both conveyor belts have not indexed within anappropriate amount of time. This forces the vision/robot control systemto flush the contents of its current parts FIFO and index one or both ofthe conveyor belts 102,104.

Conveyor Indexing Control Task

The Conveyor Indexing Control Task 680 initiates the indexing of eachrespective translucent indexing conveyor 102, 104 and the task isinitiated by the Conveyor Initiation task 690. All signals affecting themotion of the conveyors 102, 104 are routed through the Conveyor Controltask 680.

As shown in FIG. 8, the first step of the Conveyor Indexing Control task680 is to check for the LAST PICK signal 692,696 internally generatedfrom the Robot Control Task 650 and indicating that the last needlepick-up from the respective infeed translucent conveyor 102, 104 hasbeen completed by the Adept® robot 108. Alternatively, the ConveyorIndexing Control task 680 awaits for the INDEX CONVEYOR EARLY (1 and 2)signals 631,632 internally generated from the Vision Control task 660when no needles are recognized in the current camera FOV. As a result ofreceiving the LAST PICK signals 692,696 from the robot task, theConveyor Control task will generate a corresponding INDEX CONVEYOR 1signal 698, or, an INDEX CONVEYOR 2 signal 699, for receipt by the PLC620. It is understood that the Adept® robot controller must request thePLC 620 to index a translucent indexing conveyor 102, 104 after pickingup the last needle from the respective conveyor. This signal will causethe corresponding conveyor 102, 104 to abort processing and initiateindexing of the belt.

After receipt of both INDEX CONVEYOR 1 or INDEX CONVEYOR 2 signals698,699 from the robotic assembly, the PLC 620 commands the translucentindexing conveyors 102, 104 to index and generates a correspondingCONVEYOR 1 SETTLED signal 641 or, a CONVEYOR 2 SETTLED signal 642 forreceipt by the Conveyor Control Task 680. Note that the CONVEYOR 1SETTLED signal 641 and the CONVEYOR 2 SETTLED signal 642 are raisedapproximately 2 seconds after the PLC has been requested by the robotcontrol task 650 to index conveyor 102, 104. The Conveyor Control Task680 then informs the Vision Control task 660 to begin needle imagingupon receipt of internal control signals 641',642' that correspond tothe respective CONVEYOR 1 SETTLED and the CONVEYOR 2 SETTLED signals631,632. Once the indexing conveyor 102, 104 has been indexed and thecorresponding CONVEYOR SETTLED signal 641,642 has been received, theVision Control Task 660 may begin needle recognition in thecorresponding cameras's FOV. Specifically, as will be explained below,the cameras 105, 105a above conveyor 102, 104 each take a snapshot ofthe respective field of views at respective illuminated portions 101,103of the translucent conveyors and the Vision Control task 660 willcontrol the processing of the image to make a determination of whether arecognizable needle is present each camera's field of view.

At this point, a distinction must be made between the mere presence ordetection of a needle in the field of view and the presence of a"recognizable" needle. A needle may be present, but, for a variety ofreasons, the Vision Control Task 660 may not be able to determine itspositional coordinates until the camera vision parameters are changed bythe execution of an auto-imaging algorithm which automatically adjuststhe iris and vision system lighting parameters of each camera so thatthe cameras may subsequently obtain enhanced images that may beprocessed. During steady state, when the vision task has already"recognized" a needle in its respective field of view, the auto-imagingalgorithm is not repeated. Details of the auto-imaging algorithm will beexplained in detail below.

Vision Control Task

The Vision Control Task 660 controls and processes the images taken byeach of the two camera assemblies 105, 105a. Since the timing of the twotranslucent conveyors are phased, only one camera is operating at onetime.

Specifically, as shown in FIG. 8, the Vision Control task 660 interfaceswith each respective camera 105,105a to identify the needle locations ofrecognizable needles in that camera lens's respective field of viewencompassing an area located at respective illuminated platforms101,103. The Vision Task 660 then processes the positional andorientation information of the identified needle locations and writesthose locations to the Robot Task FIFO 655 via data lines 697. Asmentioned above, the Vision Control task is additionally responsible forinitiating an early conveyor index if no needles were imaged in a camerafield of view.

As described briefly above, the Vision Control task runs each timeeither conveyor 102, 104 completes indexing. It is initiated to beginneedle recognition upon receipt of either a CONVEYOR 1 SETTLED signal631 or CONVEYOR 2 SETTLED signal 632 which is generated by the PLC 620and routed through the Conveyor Control task 680 each time respectivetranslucent indexing conveyor 102, 104 has ceased indexing. EachCONVEYOR SETTLED signal 631,632 goes high (logic "1") approximately two(2) seconds after the PLC has been requested by the Adept® robot toindex a translucent indexing conveyor. Each of the CONVEYOR SETTLEDsignals 1 and 2 (631,632) remain high until the PLC 620 receives thenext respective INDEX CONVEYOR 1 or 2 signal 698,699 from the RobotControl and Conveyor Control tasks.

The Vision Task 660 activates that camera which is associated with theconveyor settled signal. When activated, the camera 105,105a takes apicture of the backlit areas 101,103 of the conveyor belt 102, 104. Anyimage obtained is preferably converted to binary image data forsubsequent digital processing. The Vision Control task 660 utilizes"vision tools" to detect acceptable needles, and places the coordinatesof acceptable needle pick-up points in the FIFO buffer 655 for the Robottask. An "acceptable" needle in the backlit areas is a needle thatmeasures within the tolerances of the needle parameters that have beenpreviously accepted during the needle changeover procedure. The needlechangeover procedure is a procedure to inform the infeed system softwareof the type and size of the needles in the current batch to be processedand must be executed before making needle batch changes as to bediscussed below. Specified needle tolerances are for the needle radius,barrel width, angular characteristics of the needle with respect to therobots, and the calculated area as computed from the needle parameters.

Auto-Imaging Algorithm

As mentioned above, if a detected needle is unrecognizable, theauto-imaging algorithm is invoked to change the camera visionparameters. Thus, after the binary image data is processed, adetermination is made as to whether the needle image is of the specifiedradius, whether the needle image is of the specified barrel width,whether the needle image has the specified angular characteristics, and,whether the needle image area is within the specified tolerance. If anyof these criteria are out of specification, then an auto-imagingalgorithm is executed which functions to take a series of pictures ofthe same needle image at the respective camera's field of view tothereby enhance the needle image for better needle recognition byimproving the vision parameters between pictures. Thus, after each ofthe series of pictures is taken, the auto-imaging algorithm willautomatically adjust the camera's iris and vision system lightingparameters to enable the vision system to image the needles properlywithin the camera's field of view. For example, when adjusting thelighting of the fields of view, certain camera vision parameters such asthe gain, offset, and binary threshold may be modified. The auto-imagingalgorithm is executed until a needle is recognized in each camera'sfield of view and is not repeated until a needle changeover is executed.

Even when the cameras 105,105a controlled by the Vision Control task 660are adjusted, needle images may still not be imaged properly. This isbecause each camera's field of view utilizes a backlighting source andneedles that overlap, touch with each other, or, are clipped by field ofview edge boundaries will not be considered for recognition. Thus, theVision Control task will make a determination of whether the needlesoverlap or touch each other, and, will determine whether the needles aretoo close to the edge of the field of view.

After all of the possible needles are recognized, the Vision Controltask will calculate the needle pick-up coordinates of the acceptableneedles and place them in the Robot Control task FIFO buffer 656 toenable the robot to pick and place the acceptable needle onto theprecision conveyor. In the preferred embodiment, the maximum number ofneedles that can be recognized during each dwell cycle of eachtranslucent indexing conveyor is three (3). If less than one or if noneedles are recognized, a robot may be signaled to index thecorresponding conveyor early, causing the vision system to abort itsprocessing as described above.

Vision Control Task 660 is responsible for limiting the number of needlelocations written to the FIFO to three, since the Robot Control Taskwill pick and place a needle for every needle location passed to theFIFO 655. In the preferred embodiment, the Vision Task is limited tooperate for five seconds per indexing conveyor cycle.

The Vision Control Task 660 performs error recovery on three types oferrors. These errors are grouped as imaging errors, processing errors,and gross errors. The gross errors cause the Task Manager error recoveryto respond and stops the Vision Control Task 686 immediately. When animaging error occurs, the Vision Control Task 660 suspends all executionon the current FOV and requests an early index of the conveyor belt bygenerating either INDEX CONVEYOR 1 EARLY or INDEX CONVEYOR 2 EARLYsignals 631,632 as discussed above. Receipt of these signals causes noneedles to be placed in the parts FIFO and forces both vision/robotsystems to pass on the current FOV of needles. If a processing erroroccurs, the Vision Control Task suspends all processing on the currentneedle and begins processing a new needle in the same FOV if anotherneedle is available. As a result, the Vision Task does not insert theneedle into the parts FIFO.

Conveyor Initiation Task

The Conveyor Initiation Task 690 functions to initiate the ConveyorIndexing Control Task 680 and is started whenever the ROBOT ENABLEsignal 619 is raised from the PLC 620. Once started, this task requestsan INDEX INFEED CONVEYOR 1 (102, 104), signal 637, then waitsapproximately two (2) seconds, and requests an INDEX INFEED CONVEYOR 2(102, 104), signal 639, as shown in FIG. 8. The task 690 is thenterminated and is not restarted again until the ROBOT ENABLE signal 619is lowered and raised again.

Task Manager

The Task Manager 640 initializes the software and hardware I/O signals,the global variables, and the vision/robot system tasks. Once thevision/robot system tasks are running, the task manager monitors theintegrity and status of each task currently running and the resourcesthat are controlled by these tasks. The status poll signals 647a-647fare indicated in FIG. 8. The resources are the robot, communicationports, and the I/O signal lines. The Task Manager reports any errors tothe PLC, via the SYSTEM FAIL signal 622, and the SCADA node, via theSCADA Node Interface Task 695. The SYSTEM FAIL signal 622 is generatedwhenever a robot (as detected by the Task Manager) has recognized agross error which prevents it from continuing operation. This signal isactive-low and remains low until the Adept robot is reset. Thus, the PLCmust lower the ROBOT ENABLE signal 619 immediately upon receiving thissignal.

For gross errors occurring with the vision/robot control software, theTask Manager 640 is utilized to detect and recover from these errors bycontinuously polling the status and integrity of all steady-state tasksand resources during program execution. If it is determined that a grosserror has occurred, the SYSTEM FAIL signal 622 will be raised to the PLC620 and all tasks except the SCADA Node Interface Task, the ControlPanel Task and the Task Manager will be stopped. A code indicating thereason for the last unrecoverable error will be available to the SCADANode through the SCADA Node Interface Task. In some cases, an errormessage will be displayed in the Monitor Window of the Adept robotcontroller. After the SYSTEM FAIL signal is raised, the Task Managerwill attempt to correct any problems detected on the robot and notifythe operator through the Monitor Window. In most cases, the operatorwill only need to raise the ROBOT ENABLE signal again to re-set thevision/robot control software.

Control Panel Task

The Control Panel Task 662 presents a mouse controlled panel that allowsan operator to access various software "debugging" utilities, to accessdiagnostics utilities, to control the speed of the robot, and to selectnew positions that the robot will move to for picking and placingneedles. Also, the Control Panel Task allows the operator to stop thevision/robot system tasks from executing.

SCADA Node Interface Task

The SCADA Node Interface task 695 polls the SCADA Node RS-232 interfacefor messages from the SCADA node and control computer 46. The task willact as slave to SCADA Node requests for Adept and camera set-upprocedures necessitated by product changeovers. These requests are validonly when the ROBOT ENABLE signal 619 is deactivated.

Lens Control Task

The Lens Control Task 670 is initiated only when the SCADA node requestsa new product to be introduced to the vision system and is executed onlyas an off-line process. The Lens Control Task 670 accepts the new needleparameters and adjusts the field-of-view size for both cameras toaccommodate the new product size. The zoom, focus, and iris lenses areaffected by this new product introduction, as well as internal visionsystem parameters, such as gain, binary threshold, and offset, used forimaging. Once the cameras are adjusted, the task is suspended untilanother new product is introduced to the vision/robot system.

Product Changeover

Prior to enabling the robots to begin the needle infeed process, aNeedle Changeover procedure is invoked to inform the Vision and RobotControl tasks of the control system software of the type and size of theneedles to be processed. This needle changeover procedure must becompleted before making needle batch changes. If a changeover is notcompleted before the first needle batch run after power-up, an errormessage will be displayed at the FIX/DMACS (SCADA Node) screen when therobots are enabled and the robots will not run. If a changeover is notcompleted between different needle batch runs, the vision tasks will notidentify any needle being run.

Essentially, an operator of the system enters the needle parameters inappropriate units, e.g., millimeters and degrees at the FIX/DMACS screen(not shown) of the SCADA task 695 through data lines 635. Such needleparameters for use by the Vision tasks include, the needle radius andthe radius tolerance, acceptable needle angles and their tolerances,and, the needle width and the width tolerance.

In addition to inputting needle change parameters for the vision tasks,initial camera set-up parameters associated with the particular batch ofneedles to be processed are also input through the SCADA Node for use bythe system. The software utilizes the information provided by the uservia the SCADA Node to automatically adjust the lens for the correctfield-of-view size, focus, and zoom parameters prior to enabling therobots.

Precise Positioning

For automatic swaging to take place at the swaging station 200 it isnecessary that the needle be precisely oriented within the universalgripper of the rotary swage dial. Thus, the transfer of the needle 39from the engagement jaws 77,79 of the boat 70 to the universal gripper(indicated as step 26 in FIG. 3 and explained in detail below)necessarily requires that each needle 39 be in a precisely orientedposition. Efficient usage of the robotic arms and the algorithmdescribed with respect to FIG. 8 provides that the robotic assembly 108may load a needle by its barrel in a conveyor boat in one of twopossible orientations. Then, to ensure that each needle is uniformlyoriented for transference to the universal gripper, a needle orientationdevice ("plow") 111 is provided as shown in FIGS. 5 and 10 to orienteach needle while engaged between jaws 77,79 on conveyor boat 70 to asingle needle orientation. The plow comprises an elongated arcuate blade80 protruding from a mounting bracket 81 as best shown in FIGS. 10. Inthe preferred embodiment shown in FIG. 5, the plow is mounted at a fixedlocation along the precision conveyor 106 to enable arcuate blade 80 toscoop needle 39 positioned on the conveyor boat 70 while in forwardmotion. After contact is made, the arcuate portion of the needle 39 islifted and rolls over the arcuate blade 80 of the plow 111. Provision ofthe plow 111 ensures that each needle conveyed to the suture swagingstation is oriented in the same direction.

Another mechanism is provided for further orienting the needle upon theprecision conveyor boat is the needle pre-positioning assembly 95illustrated in FIGS. 10 and 10(a). The pre-positioning assembly 95comprises a pulley 99 driven by an extended drive shaft from Camco drivemotor 62 and timing belt 97 for rotating a cam 98 as shown in FIG.10(a). Cam follower 91 is provided for rotating the pre=positioningassembly about shaft 96, thereby actuating arm stop 93 to reciprocatefrom a first position above the engagement jaws 77,79 of conveyor boat70, to a position that enables blade 94 of arm stop 93 to bear upon thebarrel end 44 of needle 39 while the precision conveyor boat 70 isconveyed in the forward direction as indicated by the arrow in FIG. 10.Impeding the forward motion of the needle 39 by blade 94 forces theneedle to move within engagement jaws 77,79 of the conveyor boat 70 sothat the engagement jaws 77,79 engage the needle at a precise locationon its barrel portion. Note that the cam 98, as driven by timing belt97, is designed so that the arm stop 93 reciprocates in a timed relationwith the forward motion of the conveyor boat 70 so that each needle uponeach boat 70 is further oriented. After the needle is oriented, the armstop 93 is reciprocated to its position above the conveyor boat 70 toawait the next needle for further orientation.

After the precision conveyor boat 70 is equipped with a needle 39oriented in the proper direction in the manner described above, it isconveyed to the precision transfer assembly for subsequent transfer tothe automatic swaging station 200.

Precise positioning and the Moveable Hard Stop Assembly

After the needle 39 has been plow oriented in the conveyor boat 70 andpre-positioned as previously described with respect to FIGS. 10 and 10a,it is conveyed to a precision positioning station for precise placementbefore hand-off to the automatic swaging system 200. The precisepositioning station and a moveable hard stop assembly 82 is illustratedin FIGS. 11(a) and 11(b) where FIG. 11(a) is a top or plan view of theapparatus and FIG. 11(b) is an elevation end view of the apparatus. Thehard stop assembly 82 illustrated in FIGS. 11a and 11b is the mechanismused for executing a hard stop of the needle conveyed in conveyor boat70 when the boat has reached the end of its destination at the hand-offpoint for the needle swaging station. The hard stop 84 (illustrated inFIGS. 12(a) and 12(b) provides a precise positioning surface for theneedle in boat 70. Typically, the hard stop 84 provides positioningwithin an accuracy of 0.001 inches of a denoted reference positionsubsequently used for swaging. The hard stop of the present inventiondiffers from the knife blade stop described with respect to the parentapplication inasmuch as the knife blade stop in the parent applicationwas a fixed stop mechanism whereas the apparatus illustrated in FIGS.11a and 11b is a moveable stop mechanism. The moveable stop assembly 82is reciprocated out of the way to provide clearance for the conveyorboat 70 as it continues its downward travel to return to the oppositeend of the conveyor.

As the conveyor boat 70 reaches its final position as illustrated inFIG. 11(a) the moveable hard stop 84 is reciprocated inwardly towardsthe precision conveyor to receive the butt end of the needle 44 onneedle face 84a as illustrated in FIGS. 12(a),(b). As the boat 70arrives at its final location, the gripping jaws 146,148 (illustrated inFIGS. 21(a)-(c)) of the swage device arrive on the opposite side of theneedle hard stop 84. The needle is thus restrained during handoffagainst downward movement by the needle face 84a of hard stop 84, fromside-to-side movement by the jaws 77, 79 of the conveyor boat 70 againstrearward motion by the conveyor boat 70 and against forward motion bythe face of universal gripper on the swage machine which is to receivethe needle. The universal gripper also has a pair of jaws 146,148 whichengage the needle to prevent side-to-side motion after transfer iscomplete. After the jaws 77, 79 are opened and the jaws 146,148 of theuniversal gripper are closed, the hard stop 84 is reciprocated in thedirection of the arrow A in FIG. 11a to provide clearance for movementof jaws 77,79 on boat 70 and for movement of the butt end of the needleas it is moved out of position by the universal gripper. To providefurther clearance for the butt end of the needle, and to avoiddislodging it from its precise position, the trailing face of the hardstop 84 is tapered as illustrated at 84b in FIG. 12(b).

The hard stop 84 is spring mounted in a pivot arm 85 by means of a pivotpin 86 and a coil spring 87 which maintains the position of the stop,but provides breakaway capability for the stop in the event ofmisalignment of the precision conveyor. The breakaway prevents anydamage to the conveyor boat 70 from the hard stop 84 in the event of anymalfunction of the device. The pivot arm 85 is pivoted about pivot point88 by means of a guide roller 89 and a face cam 90 which is rotated byan extended drive shaft from the Camco drive motor 62 through belt driveassembly 91.

The face cam 90 is illustrated in FIG. 12(c) and provides for reciprocalmovement of the hard stop mechanism of approximately 1/8 of an inchduring each dwell period. The cam surface is illustrated with A-A' beingthe reciprocal distance, dwell period B, being the retracted dwellperiod, dwell period D being the engaged dwell period, and C being oneof the transition periods. The pivot arm 85 is pulled into engagementwith the face cam by means of a tension spring 92. As the face cam 90 isrotated, the hard stop is held in its engagement position forapproximately 195° of rotation of the face cam and held in its retractedposition for approximately 120° of travel with transition periodstherebetween. The ratios of belt drive 91 are chosen to provide onecycle of rotation for the face cam 90 for each step advance of theconveyor boat 70.

Suture Drawing and Cutting

Simultaneously with the positioning and transfer of the surgical needlesto the universal gripper on the swage dial, predetermined lengths ofsuture are being drawn, tipped and cut by the suture drawing and cuttingstation 300, as indicated in steps 18-24 of FIG. 3(a).

FIG. 15 illustrates a front elevational view of one designed embodimentof a servo tower 300, similar to that shown in FIGS. 2-6, and shows thesuture path therethrough. Suture 304 is pulled off one end of a supplyroll 302 mounted to one side of the servo tower, through the center ofan annular guide disc 305, and into a mechanical tensioner 306. Themechanical tensioner can comprise a stationary guide frame 308 and apivotally mounted guide frame 310, pivotally mounted about a pin 312 atthe lower end of the stationary guide frame. Each of the stationaryguide frame and the pivotally mounted guide frame has a series of spacedguide elements, each with a central guide aperture therein, which arealternately interleaved, such that the spaced guide elements of thepivotally mounted guide frame alternate with the spaced guide elementsof the stationary guide frame. The pivotally mounted guide frame 310 isspring biased about the mounting pin 312 to rotate the top thereof awayfrom the top of the stationary guide frame, such that the sutureextending between the alternating stationary guide frame elements andthe pivoted guide frame elements is placed under tension while beingpulled therethrough.

The suture then travels over idler roller 326, and extends to and iswrapped twice around a tension roller 314 which is mounted on one end ofa torque motor 316, (illustrated in dotted lines in FIG. 15) whichapplies a given tension to the suture as it is pulled through the servotower by the first and second gripper assemblies 331, 332. The grippingassemblies alternate in a hand over hand advancement as previouslydescribed in U.S. Ser. No. 08/181,595, entitled "Suture Cutting System,"the disclosure of which is incorporated herein by reference thereto.Each different suture size and material should have a different tensionapplied thereto as it is drawn through the apparatus. The torque motor316 provides a different tension force for each different suture sizeand type, and the specific tension force(in grams per volt to be appliedby the torque motor) is downloaded from a computer program at eachsuture batch changeover. The proper tension is important for severaloperations described herein, and is particularly important for thecutter assembly to operate while providing a clean neat cut without abroom effect.

The suture then extends to an out-of-suture sensor positioned at 317,and then through a knot detector 320. The suture 304 then travels to asecond idler roller 328 to change direction again, from which the suture304 extends vertically downwardly through a heated tipping assembly 330,which heats and ultimately stiffens a small length of the suture, atwhich small length the suture is subsequently cut and the cut tip isinserted into and swaged to a needle.

The suture 304 then extends downwardly from the tipping assembly to alarge idler roller 335 mounted near the bottom of the machine having anappropriately 7 inch diameter, at which the suture reverses directionand travels vertically upwardly to the first and second gripperassemblies 331, 332, to the suture cutter assembly 334 and a sutureswaging During the insertion operation, the cut suture end is guided bya funnel shaped aperture 270(a),271(a) in a suture guides 270,271 intothe aperture in the end of a needle, after which a moving anvil 273 ismoved relative to a stationary anvil 274, of a swage die, to swage andattach the needle to the suture.

In this embodiment, after initialization, one gripper assembly will bein a home position, 2" below the face of the swage die mounting surface,allowing a 2.03" movement from the home position to an insert position.A proximity switch is located on each tower at 2" below the face of theswage die mounting surface to set the home position during aninitialization procedure.

Assuming that the machine is being initially set up to cut a desiredlength of suture, the cutter assembly 334 will be moved to apredetermined vertical position in the swaging machine by operation ofthe handcrank attached to gearbox 341. This is done by aligning apointer for the cutter assembly with a vertical scale 356 positioned onthe side of the swaging machine, similar to the vertical scale 357 shownabove for the tipping assembly.

The cutter assembly includes a proximity switch thereon, and during aninitialization procedure, the position of a gripper assembly is detectedby the proximity switch, and that position is set in memory to set theservo gripper bottom position 332 during subsequent normal operation ofthe machine. The tipping assembly is also moved to an appropriateposition in the machine as described hereinbelow.

FIG. 9 shows the right gripper 332 positioned slightly below the cutterassembly 334 so that the indefinite length strand will be gripped whenthe definite length swaged strand is cut. Thus, the upper left gripper331 now grips the suture material 304 having a tipped end 358 and it nowbecomes the lead gripper. The next cycle begins with the lower gripper332 vertically drawing the material 304 along the height of the drawingtower 300 for the long stroke to position the next strand to be cut forinsertion within the surgical needle.

During this operation, assume that the upper gripper assembly 331 hasjust moved to its home position. At the home position, the gripperassembly 331 stops and waits a predetermined time, during which a needleis preclamped in an insertion position in the swaging station 200, andthen moves to the insert position. The following operations are thenperformed substantially simultaneously. The bottom gripper assembly 332closes, a tipping operation is performed simultaneously at the tippingassembly 330, and the swage station is simultaneously actuated to swagethe needle end around the suture, attaching it thereto.

Thereafter, the cutting assembly 334 is activated, cutting in the tippedarea to cut the suture to the given length. Thereafter, the uppergripper assembly 331 opens, and the assembly 331 returns to the bottomposition, and simultaneously therewith the lower gripper assembly 332moves up to the home position, and the cycle is then repeated.

After removal of the swaged needle and attached suture length from theapparatus, it is subjected to a sterilization operation, during whichthe suture length incurs some shrinkage. Accordingly, the cut lengths ofsuture must be cut to lengths slightly longer than their desired(orlabel) final lengths to compensate for such shrinkage.

The following table gives, for silk suture, in the left column thecommercial(or label) suture length, in the middle column the low servoposition of the low gripper assembly below the face of the swage diemounting surface, and in the right column the cut length of suture priorto shrinkage. VICRYL shrinkage during sterilization is approximately 3%of the table values for silk.

    ______________________________________                                        18"         servo - 16.51                                                                           allowed for 18.350"                                       27" servo - 25.51 allowed for 27.380"                                         30" servo - 28.51 allowed for 30.380"                                         36" servo - 34.51 allowed for 36.380"                                       ______________________________________                                    

As described above, after heating of a predetermined length of suture atthe tipping assembly, the suture must cool to allow setting andhardening of the suture material prior to cutting of the suture at thehardened length and insertion of the cut stiffened end into a needle.This cooling of the suture is provided in this embodiment by allowing adiscrete number of machine cutting cycles to occur between tipping ofthe suture and cutting of the suture. This is provided by allowing apredetermined long length of suture travel between the tipping assemblyand the cutter assembly. Hence, the suture tipping assembly 330 ispositioned near the top of the servo tower, and after heating thereat,the suture travels to the bottom of the machine, around the large idlerroller 335, and then back upwardly to the cutter assembly 334. The largediameter of the idler roller 335, relative to the other idler rollers326, 328, is provided because the small length of suture which has beenheated at the tipping assembly 330, has begun to harden and set by thetime the heated section reaches the large idler roller. The largediameter thereof facilitates the suture to travel therearound withoutpicking up a permanent curved set from the large idler roller, as it isdesirable for the suture to be straight, without any curve, when it issubsequently cut and inserted into a needle. The idler rollers 326 and328 typically have a 0.5 inch diameter, whereas the large diameterroller 335 has a diameter preferably greater than 6.0 inches,approximately 7.0 inches in one embodiment.

The operation of the machine depends upon a discrete whole number ofmachine cutting operations to be performed between the tipping andcutting operations. Accordingly, for each different length of cutsuture, the tipping assembly 330 must be positioned at a differentpredetermined position within the machine for the tipped section ofsuture to be precisely and correctly positioned at the cutter assembly334 after a given number of machine cycles.

The following table gives in its columns, proceeding from left to right,the label suture length, the actual cut suture length, the number ofmachine cycles or increments provided between tipping and cutting, thetotal travel length of the suture between tipping and cutting, thetipping assembly vertical position above the table top, and the tippingassembly scale pointer position above the table top (explained ingreater detail hereinbelow).

    ______________________________________                                        SUTURE LENGTH                  ABOVE TABLE TOP                                LABEL ACTUAL   INCREMENTS TOTAL  TIPPER C                                                                             POINTER                               ______________________________________                                        18 IN.                                                                                19 IN. 6            114 IN.                                                                            27.64 IN.                                                                            25.89 IN.                               27 IN.   28 IN. 4   112 IN. 25.64 IN. 23.89 IN.                               30 IN.   31 IN. 4   124 IN. 37.64 IN. 35.89 IN.                               36 IN. 36.25 IN. 3 108.75 IN. 22.39 IN. 20.64 IN.                           ______________________________________                                    

FIG. 16(b) illustrates an enlarged front elevational view of the suturetipping assembly at which a small length of the suture is heated tostiffen the suture material after subsequent cooling thereof, inpreparation for cutting a given length of the suture and inserting thelead cut end of the suture into the end of a needle for swaging thereto.

FIG. 16(b) illustrates the movement of the tipping assembly 330 along avertical scale 357 provided adjacent to the tipping assembly 330. Thevertical position of the tipping assembly in the machine is adjustableby a handcrank 360 and precision lead screw 361, similar to thepositioning mechanism for the cutter assembly as described hereinabove.As the handcrank is rotated, the vertical position of the tippingassembly 330 in the machine is changed, and is precisely positioned byreading a pointer 359 attached to the tipping assembly on the scale 357.A chart is provided for the machine which gives, for each desired lengthof suture, the appropriate position for pointer 359 of the tipperassembly 330 on the vertical scale 357, and a similar position for thecutter mechanism 334 on the vertical scale 356.

In this embodiment, the position of the cutting mechanism along thedrawing axis is continuously adjustable to provide an infinite number ofpossible different lengths of cut suture. For each different cuttingposition of the cutting mechanism, the tipping mechanism is adjustablypositioned at a different predetermined position in the apparatus toprovide for the tipped section of suture to be precisely positioned atthe cutter mechanism for a discrete number of machine cycles.

In an alternative embodiment which does not have this infiniteadjustment feature, several standard lengths of suture are accommodatedby several standard positions which are fixed in the machine by pinswhich secure the cutter mechanism to the machine frame by pin receivingholes in the machine at the standard positions. For example, the cuttermechanism might be moved to a position for cutting 18" sutures and besecured to the frame by the placement pins being inserted into the pinreceiving holes in the machine for 18", sutures. The cutter mechanismmight also be moved to positions for cutting 27", 30", or 36" sutures bymoving the placement pins to the pin receiving holes in the machineprovided for those length sutures. Each different position can have aseparate proximity switch provided therefor, which indicates the cuttingmechanism position to the controller, which then downloads theappropriate servo gripper bottom position. The appropriate tippingmechanism position is known for each different cutter mechanismposition.

FIGS. 9(a) and 9(b) illustrate a heater 362 in the tipping assembly 330and the vertical movement of the suture 304(a) down (front view, FIG.16(b)) and through (top view, FIG. 16(a)) a suture tipping aperture 364,FIG. 16(a), positioned on the right side of the tipping assembly. FIG.16(a) illustrates further details of the flow of heated air through thetipping assembly and its control to selectively heat and tip the suture.As described previously, the tipping assembly 330 is mounted near thetop of the machine so that it takes a discrete number of machine cyclesfor the suture to reach the cut position. This gives the tipped areatime to cool down before the cutting and insertion operations. Thetipping assembly operates by flowing air supplied at a regulatedpressure through an inlet air duct 366 at a regulated flow rate, in oneembodiment 195 CFH (Cubic Feet per Hour), over a heater coil mountedwithin an outer heater casing 368. Air is supplied to a flowmeter at aregulated pressure required to maintain 195 CFH of air flowing over theheater coil. A thermocouple 370 is positioned in the air flow at thedischarge end of the heater casing 368, to monitor and control the airtemperature through a controller in a programmable logic controller(PLC). The tipping assembly 330 is operated at various temperaturesbetween 200° F. and 550° F. depending upon the particular suturematerial to be run. The particular temperature is a down loadedparameter from an operating program at each suture batch changeover. Thetipping assembly guides the suture and provides a 2.000" long heatingaperture 364 for the tipping length.

The constant flow of heated air at the outlet of 368 flows either 1)through the heating aperture 364 in which the suture 304 isintermittently stopped and positioned during a tipping operation, or 2)alternatively the heated air is dumped into the surrounding atmospherethrough a diverter channel 372, illustrated in FIG. 16(b). The flow ofhot air is controlled by an air cylinder 374, under control of asolenoid 376, which controls the flow of actuating air through air tubes378, 380. The air cylinder 374 controls the position of a retractableslide element having a flow aperture therein which is selectivelypositioned in front of either 1) a channel into the heating aperture 364or 2) the diverter channel 372, depending upon the position of theslider element which is controlled by an air cylinder.

As an example, the following control parameters have been establishedfor heat tipping of Braided VICRYL sutures sizes 1, 0, 2/0, 3/0 and 4/0.The suture tension refers to the tension force in grams which thetension roller 314 and torque motor 316 apply to the suture as it isbeing drawn through the machine by the grippers.

    ______________________________________                                                Tipping Temp.                                                                              Tipping Time                                                                             Suture Tension                                  Suture Size +/- 25 deg. +/- 25 Ms +/- 25 Grams                              ______________________________________                                        4/0     375 F.       380        275                                             3/0 395 F. 380 275                                                            2/0 410 F. 380 275                                                            0 425 F. 380 275                                                              1 435 F. 380 275                                                            ______________________________________                                    

As a further example, the following control parameters have beenestablished for suture tension and heat tipping of silk sutures sizes2/0, 3/0 and 4/0. In the following table the left column listscommercial needle types, the next column needle sizes, the next columnsuture sizes, the next column suture tension in grams applied by thetension roller 314, the next column tipping dwell time, the next columntipping heated air flow in standard cubic feet per minute, and the rightcolumn suture tipping temperature.

    ______________________________________                                        SILK SUTURE AND TIPPING PARAMETERS                                                                                   Tipping                                                                             Tipping                             Wire  Suture Tipping Air Tem-                                                Needle Size Suture Tension Dwell Flow perature                                type (0.000") Size (grams) (seconds) (SCFM) (° F.)                   ______________________________________                                        Tolerance                                                                            N/A     N/A     (±10                                                                              (±0.020)                                                                          (±5)                                                                             (±15)                                grams)                                                                     CT-1 39 2-0 275 0.380 190 300                                                 CT-2 39 2-0 275 0.380 190 300                                                 SH 26 2-0 275 0.380 190 300                                                   SH 24 3-0 275 0.380 190 300                                                   SH 22 4-0 275 0.380 190 300                                                   SH-1 22 3-0 275 0.380 190 300                                                 SH-1 18 4-0 275 0.380 190 300                                               ______________________________________                                    

The previous tables are for braided VICRYL suture and silk suture, andsimilar tables could be developed for other suture materials such asEthibond® (braided polyester) and monofilament and braided nylon.

The suture drawing, tipping and cutting is more completely described inU.S. Ser. No. 08/804,478, U.S. Ser. No. 08/083,573, and U.S. Ser. No.08/804,477, attorney dockets 8924Z, 8924Y, 8924X, all of which areentitled "Suture Cutting System," the disclosures of which areincorporated herein by reference thereto.

The Swage Dial Drive Assembly

The drive assembly for the swage dial 150 is illustrated in FIGS. 13(a),13(b) and 8. As illustrated in FIG. 13(a), the swage dial assembly 150includes a swage dial 110 and a cam dial assembly 120 both of which areindependently driven by the drive means of the present invention. Adrive motor 140 drives both of these dials through a first indexingdrive transmission 142 and a second indexing drive transmission 144through a 90° reduction transmission 141 and are coupled together with atiming belt 143. The indexing drive assemblies 142,144 are "CAMCO"Indexer Drivers Model 350RGD 4H24-360 with a 10 to 1 reduction intransmission 141 and an oscillation motion for the cam dial assembly120. As will be hereinafter explained with respect to FIGS. 10-11, thefirst indexing CAMCO drive includes 180° of drive and 180° of dwell forevery revolution of the transmission drive 141 which results in a 90°drive dwell cycle for the first indexing drive 142. The first indexingdrive 142 drives shaft 130 about a single drive axis D-D' illustrated inFIGS. 7-8. It is journalled for rotation in bearings 131a,b,c, and d andis secured in place by drive cap 132 and a compression drive collar 133which is connected to the output of the first indexing drive 142. Amodular frame assembly 134 supports each of the drive elements about thecentral drive axis D-D'.

The second indexing drive 144 also includes 180° of drive, a second 60°of drive, a 30° dwell, a 60° drive and a 30° dwell for each revolutionof the input drive from belt means 143, and the indexing drive 144 isphased with the drive and dwell cycles of the first drive 142. As willbe hereinafter described with respect to FIGS. 10 and 11, during eachdwell period of the swage dial 110, the cam dial assembly 120 is held ina dwell position and then rotated to enable radial reciprocation of theuniversal grippers with respect to the swage dial 110.

The cam dial assembly 120 is mounted on an annular drive collar 135which connects the output of the second indexing drive 144 to the camdial plate 120 as more fully illustrated in FIG. 14. The annular drive135 is journalled for rotation on drive shaft 130 by means of needlebearings 136 to provide a single drive access D-D' for rotation of theswage dial assembly 150. The annular drive collar provides suspensionsupport and rotational drive for the cam dial assembly 120. The use ofthis annular collar also separates the cam dial and swage dial from thedrive apparatus and enables operator workspace for alignment of theapparatus and for part changes when necessary. The annular drive collar135 is bolted to the output drive flange of the indexing drive 144 asshone at 135(a).

The swage dial 110 is mounted for rotation on a ball detent clutch 114which is fixably attached to shaft 130 and enables breakaway rotationbetween clutch drive plates 112 and 114 in the event of a catastrophicjam. The clutch 114 and shaft 130 also provide suspension support androtational drive for the swage dial 110.

The annular cam drive 135 is bolted to the output of the second indexingdrive 144 as illustrated at 135a and thus provides for both suspensionsupport and rotation of the cam dial assembly 120. Likewise, thebreakaway clutch 114 provides physical support and rotational drive forthe swage dial 110 by virtue of its fixed mounting on shaft 130 at 114a.

The Swage Dial

The process for extending each universal gripper 155 for needleprocessing at each of the stations 100, 200, 400, and 500 will now beexplained. As shown in FIGS. 10(a), 10(b) and 10(c), each universalgripper 155 is connected to a reciprocating carriage 151 and a cam slide164. Cam followers 165(a),(b),(c) and (d) are mounted to a cam slide 164at one end thereof with the universal gripper at the other end. Camslide 164 is slidable within stationary guides 166,167 and is adaptedfor reciprocal movement when the cam follower 165 is actuated. In thepreferred embodiment shown in FIG. 18(a), cam followers 165(a)-(d) arerollers that fit within the cam track of a rotatable cam dial assembly120. Cam dial assembly 120 is shown in FIG. 18(a) as comprising a camdial plate 125 having a continuous cam tracks 160 which receives camfollowers 165(a)-(d) attached to universal grippers 155a,b,c, and 155d,respectively. Each cam follower 165 is positioned within the cam trackat each station for movement therein.

As illustrated in FIG. 18(a), cam dial 125 is positioned above swagedial 110 and mounted coaxial therewith. The cam dial 125 is rotatableabout a central axis and controlled by a separate rotary indexingtransmission as described previously so that it may rotate separatelyfrom the swage dial plate 110. The cam dial is driven in multiple driveand dwell cycles as previously explained, and the degrees of each phaseare diagrammatically illustrated in FIG. 18(a). FIG. 18(a) also showscam followers 165a-d in a first retracted position within the cam track160. When the dials are in this position, each of the reciprocatingcarriages and consequently universal grippers 155 are in their retractedposition as shown in FIG. 17(a) and 10(b) discussed above. To extend theuniversal grippers 155 in place at their respective stations, the camdial plate 125 is rotated in the clockwise direction with respect to theswage dial plate 110, as indicated by the arrow A in FIG. 18(a), forapproximately 25-45 degrees, forcing cam followers 165a-d in its camtrack 160 to move toward the periphery of the dial as shown in FIG.18(b). Consequently, each of the cam slides 164, reciprocating carriages151a, and the universal grippers 155 move to the extended position asshown in FIG. 17(c). To move back to its retracted position, the camdial plate 125 is rotated in the counter clockwise direction withrespect to the swage dial plate 110 for approximately 20 to 30 degrees,forcing cam followers 165a-d in the cam track 160 to move to theirretracted position (FIG. 18(a)). Consequently, the cam slide 164,reciprocating carriage 151a, and the universal gripper 155 move back tothe retracted position as shown in FIG. 17(b) and discussed above.

It should be understood that when cam dial plate 125 rotates withrespect to swage dial 110, each universal gripper 155 is either extendedor retracted by the cam track. Thus, the system is designed so that allprocesses performed at each station occur simultaneously and forapproximately the same duration of time when the universal grippers arein their extended position, for e.g., for needle pick-up, for needleswaging, or, for needle pull-testing.

When the universal gripper 155 is retracted, the needle engaged therebymay then be indexed to a different station for further processing. Toindex the needle to another station, both swage dial plate 110 and camdial plate 125 are rotated together for approximately 90 degrees toposition the universal gripper at the next station. For example, whenthe cam dial plate 125 and the swage dial plate 110 are simultaneouslyrotated 90 degrees counterclockwise in FIG. 17, the gripper 155 that hadreceived the needle at station is now indexed to station 200 for swaginga suture thereto. Similarly, after swaging, the cam dial plate 125 andthe swage dial plate 110 are simultaneously rotated counterclockwise sothat the armed needle at station 200 is indexed to the pull-testingstation 400 for pull-testing thereof. The operations performedconcurrently at each station about the swage dial increases throughputto provide an output of pull-tested armed surgical needles at a rate ofapproximately 40 to 60 per minute in the preferred embodiment.

Universal Gripper

As illustrated in FIG. 1, the rotatable swage dial assembly 150cooperates with four stations where simultaneous needle operations areperformed. In the detailed illustration of FIG. 17(a), the swage dialassembly 150 includes a swage plate 110 having four universal gripperstations 145a, 145b, 145c, 145d spaced equally thereon.

The swage plate 110 is rotatably mounted at a central hub 112 on a balldetent safety clutch 114 (illustrated in FIG. 14) and operable to rotateunder the control of a control system computer 46. In the preferredembodiment, a separate reciprocating carriage 151 is provided at eachuniversal gripper station of the swage dial assembly 150. For instance,as shown in FIG. 17(a), universal gripper station 145a includesreciprocating carriage 151a, while station 145b includes reciprocatingcarriage 151b, station 145c includes reciprocating carriage 151c, andstation 145d includes reciprocating carriage 151d.

Mounted to each reciprocating carriage 151a,b,c,d for retractablemovement therewith, is one universal gripper 155, two of which are shownconnected to gripper mounts 150(a) and (d) in FIG. 17(a).

As previously mentioned, each reciprocating carriage 151 a,b,c,d anduniversal gripper 155 connected thereto is movable from a retractedposition to an extended position. When the gripper 155 is in theretracted position shown in FIG. 17(b), the needle 39 may be conveyed toa different station as the swage dial rotates; when the gripper 155 isin the extended position as shown in FIG. 17(c), the needle is in one ofthe active stations, such as the automatic swaging station.

The universal gripper of the present invention receives the needle fromthe precision conveyor and moveable hard stop mechanism, and transportsthe needle through the swage operation in which a suture isautomatically inserted into the barrel end of the needle, and the metalof the needle swaged about the suture. As can be appreciated, when theopening in the barrel is only 0.0106 and the suture diameter is 0.0088,a high degree of precision handling is required, particularly so whenthe insertion and swage operation need to be completed in approximately0.5 seconds in order to maintain a 30 to 60 needle per minute cyclerate. The universal gripper also transports the needle through the pulltest station in which the suture bond is tested and to the packagingarea, where the armed suture (needle and suture assembly) is bundledwith other armed sutures for future packaging.

In FIGS. 14(a) (b) and (c), both the slide portion 164 and the gripperportion of the universal gripper 155 are illustrated, with a pair ofneedle gripping jaws 146 and 148, each having a portion of a needlereceiving indent 157 formed therein. Each of the jaws have a reciprocalslide portion 146(a), 148(a) formed as an integral part, which slidesreciprocate in a channel 162 formed in housing member 174, The jaws 146and 148 are biased to each other and to a closed position by a springmember 160. The jaws are opened by a pair of moveable pivot linkages166, 168 which are mounted to and actuated by plunger 170, so that whenplunger 170 is depressed, the linkages 166, 168 are moved outwardly,drawing the jaws 146 and 148 with them. The plunger 170 is actuated by acam driven by an air motor at each automatic station to open and closethe jaws about a needle 39.

In the apparatus, a plurality of universal grippers are employed,preferably 4, each of which grips a single needle at positioning, atswaging, at testing and at off-load, as previously described. As theuniversal gripper is moved into position, the jaws 146,147 are openedand the gripper is reciprocated towards the needle so that open jaws arepresented on each side of the needle. The jaws of the precision conveyorboat 70 are then opened, and during transfer, the needle rests on themoveable hard stop 96. The jaws 146,148 of the universal gripper arethen closed to grip the needle and the moveable hard stop 96 isreciprocated out of engagement with the needle, and away from the jawsof the precision conveyor to allow the precision conveyor to advance thenext needle into the needle transfer position.

The step of loading of the individual precisely oriented surgical needle39 from the precision conveyor boat 70 and the moveable hard stop 96onto the universal gripper 155 at the precision loading station 100involves a compound movement on the part of the universal gripper. Sincethe needle is gripped in detents formed in the jaws of the conveyor boat70, and since one of the jaws of the precision conveyor boat 70 isfixed, it is necessary for the universal gripper to transcend a compoundmovement when removing the needle from the conveyor boat jaws. If astraight reciprocal movement is attempted, the needle is stripped fromthe jaws of the universal conveyor by the detent in the fixed jaw of theconveyor boat 70. This compound movement is found at both the precisionposition station 100 and the swage station 200, which also uses fixedand moveable jaws. The use of a fixed jaw substantially improves theaccuracy of the alignment of the needle with the suture at the swagestation.

In the frontal view of the universal gripper as shown in FIGS. 15(a) and(b), jaws 146 and 148 of the universal gripper 155 extendperpendicularly from the gripper to engage the barrel end 44 of thearcuate needle 39.

FIGS. 15(a),(b) also illustrates two roller cam surfaces 172, 180 whichact on the universal gripper. A cam surface 172 is found at each of thefour stations,(Precise positioning, swage, test and off-load) and isused to open jaws 146 and 148 of the universal gripper at each station.FIGS. 7 and 8 also illustrate three pneumatic drives 176(a), (b) and(c)which actuate rollers 172(a), (b) and (c) to open and close the jaws ofthe universal gripper 155 as will be hereinafter explained in greaterdetail.

FIG. 14 illustrates a typical positioning for cam 172 above the needlepull test station, wherein cam roller 172(a) is mounted on a bell crank174, which is actuated by an air cylinder 176(a). The cam 172(a) isnormally biased to a non-engaged position by spring 178.

Each of the universal grippers 155 is mounted for linear movement withrespect to the cam slide 164 by means of an off-set slide assembly, thedetails of which will be explained as with respect to FIGS. 14(a), (b)and (c). As indicated therein, the housing 174 of the universal gripperis mounted on a mounting block 175 and slide 177, and slide 177 isspring biased to a home position during reciprocation within slidecarriage 151 by spring member 179. This second reciprocal movement istransverse to the reciprocal movement imparted by cam slide 164.

Referring to FIG. 22(a),(b), roller cam 180 is used to provide thecompound off-set movement of the universal gripper as it is reciprocatedoutwardly by the swage dial cam plate 125. FIG. 17(a) illustrates atypical positioning for the off-set drive used to drive cam roller 180at the precise positioning station 100. Roller cam 180 is mounted on alinear slide 182, which is driven by an air motor 184, mounted on theswage dial frame. FIG. 17(a) also illustrates the relative motions ofthe universal gripper 155, with arrow A indicating the off-set movement,arrow B indicating the reciprocal movement which results in the radialreciprocation of the universal gripper 155 to 155a in FIG. 17(a), andarrow C indicating the rotary motion of the swage dial 110.

To accomplish the transfer of the needle to a universal gripper 155, theuniversal gripper 155 is extended and translated horizontally so thatthe face of the universal gripper is adjacent to the needle precisionconveyor boat 70 as shown in FIG. 14 and 10(a). In this position, thejaws 146 and 148 penetrate the plane of the needle 39 on either sidethereof. A load solenoid or similar device depresses a pusher arm of theprecision conveyor boat 70 to release the needle from the engagementjaws 77,79 of the precision conveyor boat 70 so that it rests on themovable hard stop assembly between jaws 146 and 148 of the universalgripper 155. Simultaneously therewith, as controlled by the controlsystem computer, jaws 146 and 148 are actuated from the non-engagingposition to an engaging position to thereby engage the needle 39 in anoriented position as shown in FIG. 22(a). The universal gripper 155 isthen off-set horizontally and retracted radially and the swage dialassembly 150 is rotated to the swaging station 200 to accomplishautomatic swaging of the suture to the needle 39.

Needle Swaging Station

The swaging operation taking place at the swaging station will now bedescribed with reference to FIG. 19, FIGS. 15(a)-(b) and FIGS.19(a)-(c). FIGS. 15(a)-15(b) illustrate the universal needle gripper 155and swaging and suture alignment dies shown in two stages of the sutureinsertion and needle swaging sequence. This sequence, and theinteraction of the dies in relation to each other, the needle, and theinsertion of the suture, accomplish the insert and swage function withminimal parts changes for each group of needle diameters and simplemotions.

After conveying the needle to swaging assembly 200 shown in FIGS. 12 and15(a), the universal gripper 155 is radially extended from the swagedial, and off-set to the side in the manner described above to positionthe suture receiving end 44 of needle 39 between the funnel shaped dieopening formed at the ends of two swage dies 273,274 as shown in FIG.22(a). As will be explained, swage die 274 is relatively fixed inposition and swage die 273 is movable laterally toward the fixed swagedie 274, as indicated by the arrow "A", to accomplish swaging of thesuture receiving end of a needle placed therebetween. A funnel shapeddie opening having an exit diameter slightly larger than the diameter ofthe suture receiving end 44 of the needle is formed when the two swagedies 273,274 are positioned adjacent each other as shown in FIGS. 15(b).

In the preferred embodiment shown in FIGS. 19(a) and 19(b), the ends ofeach of the swage dies 273,274 are provided with rectangular diecavities 283,284 respectively, to permanently swage the suture to needle39. Note that as illustrated in FIGS. 19(a),(b), The swage dies are fora small 18 mil needle, and FIG. 26(a) has been magnified 2× and FIG.26(b) magnified 100× for purposes of illustration. Different sets ofswage dies may be provided, depending upon the size (diameters) of theneedles and sutures to be swaged, and in the practice of the presentinvention, dies for needles ranging from 18 mil (0.018) to 50 mil(0.050). The die cavities illustrated in FIGS. 19(a),(b) are rectangularin shape with a 90 degree angle, and used to impart a permanent swagebond between needle and suture. Similar dies may be used with round diefaces to impart a controlled release swage bond between the needle andsuture.

To precisely position the suture receiving end 44 of needle 39 betweenthe swage die opening formed at the ends of two swaging dies 273,274,the movable swage die 273 is temporarily moved apart. In theillustration of the swaging assembly 200 shown in FIG. 19 and 15(a),swage die 273 is moved apart from the fixed swage die 274 by actuatingair cylinder 295 to provide a force upon cylinder rod 293 to enableswage die operating lever 205 to pivot about pin 206 and pull aretraction arm 297 which engages stud 298 affixed to moveable swage die273 a predetermined distance away from the fixed swage die 274. In thepreferred embodiment, lever 205 is biased by spring 209 so that themovable swage die 273 will return toward the fixed swage die by thespring restoring force when the pressure provided by the air cylinder295 is terminated.

FIG. 22(a) shows die 274 in its fixed position, and moveable die 273 inits spaced apart position prior to receiving the surgical needle 39presented by universal gripper 155. Suture alignment die 270 containingsuture guide funnel half 270(a) is positioned under swage die 273, andfree to slide laterally within limits. Suture alignment die 270 has atang 270(b) that protrudes into cavity 273a formed within swage die 273.Compression spring 273c bears against the back wall of cavity 273a andtang 270(b) such that funnel die 270(a) slides forward until it isconstrained by the inner wall of cavity 273(a). In this position, it isforward of the center axis defined by the suture receiving end of theneedle, and serves as a shelf that helps assure suture receiving end 44of needle 39 is in position for swaging. In this stage of the cycle, theparts are not positioned for suture insertion, and suture clamps365(a),(b) gripping suture 304 and stiffened end 358, are in dwell.Suture alignment die 271, containing funnel half 271(a), is fastened toswage die 274 by suitable fastening means.

While the swage dies are apart, the universal gripper 155 is extended toposition the suture receiving end 44 of needle 39 within the swageopening as shown in FIG. 22(a). Referring to FIG. 19, the universalgripper is off-set during entry and egress by cam roller 180(b), whichis driven by air cylinder 216 through bell crank 218. This off-set isnecessary to allow the needle to box step into the swage die opening 284in the fixed swage die as it is placed in position by the universalgripper 155. After positioning the suture receiving opening 44 of needle39 at the swage die opening 284, the moveable swage die 273 is movedtoward needle 39 with the resilient spring force present in spring 209that is sufficient to enable the dies 273,274 to grip and locate thesuture receiving end 44 precisely against fixed swage die 274 withoutdeforming the cavity of the suture receiving opening 44 formed therein.Concurrently, the jaws 146,148 of universal gripper 155 are opened bydownward external force on plunger 170, by cam roller 172 as describedabove, thereby releasing the needle so that its position is determinedby the grip of swaging dies 273 and 274. The motion of dies 273 and 270causes the face of suture alignment die 270 to come in contact with thecorresponding face of suture alignment die 271. The resilient forcecausing this motion is forceful enough to compress spring 273c, and movefunnel die 270(a) to the left, such that tang 270(b) is no longer incontact with cavity wall 273(a). Dimensioning of dies 270 and 271 issuch that this motion results in the formation of two funnel halves270(a) and 271(a) defining a smooth conical shape that is coaxial withthe suture receiving end 44 of needle 39.

FIG. 22(b) illustrates suture grippers 365(a),(b) moved vertically tothe insertion position, which causes stiffened suture end 358 to enterthe funnel defined at 270(a), 271(a), and be guided into the suturereceiving cavity 44 of needle 39 axially aligned therewith. Note thatthe exit diameter of the conically shaped funnel guide formed of funnelhalves 270(a) and 271(a) is preferably equal to or greater than thediameter of the suture tipped end 358 and smaller than the diameter ofthe suture receiving end 44 of the needle 39, so that the tipped end 358of the suture strand may be easily inserted therein. An enlarged detailof the suture alignment dies 270,271 and the placement of the funnelportions 270(a) and 271(a) is illustrated in FIG. 26(c). Once the strandis inserted into the suture receiving end 44 of the needle (step 27) asdiscussed above, the automatic swaging of the suture receiving cavityoccurs.

In the preferred embodiment of the swaging assembly 200 shown in FIG.19, a pneumatic air cylinder 204 provides air pressure to actuate cam275 that bears on lever 205 to pivot about pivot point 206 and drive cam207 against the end of the moveable swage die 273 to thrust movableswage die 273 toward the fixed swage die to accomplish the swaging ofthe suture receiving end of the needle placed therebetween. Air pressureis supplied to the swage cylinder 204 via ports 266 under the control ofthe control system computer 46.

After the swage die 273 has been driven to a fixed stop by the swagecylinder, the suture receiving end 44 of needle 39 has been deformed tothe desired shape defined by the swage die contours, as illustrated inFIG. 26(b). As deformation takes place, the moveable swage die 273 comesto a stop as a swage stop post which is press fit into the moveableswage die 273 strikes a reference wall cross milled into the frame ofthe swage assembly. When the swage stroke is performed, the swagecylinder drives the die and post assembly to the left (in FIG. 19) untilit is positively stopped by the lower portion of post striking the wallof the cross milled groove in the assembly frame (located under swagedie 273 in FIG. 19). This stalls air cylinder 204, so that the stroke ofthe moveable right hand die assembly shown is always the same forrepeated cycles of the machine. In an alternative embodiment, both swagedies 273,274 may be movable towards each other to accomplish swaging.

In the preferred embodiment, the degree of swage compression imparted onthe needle, and resulting strength of grip by the needle on the suture,is adjusted by precise positioning of the fixed die 274.

As shown in FIG. 19, servomotor 214 rotates a swage adjust screw 213. bydriving a belt and reduction pulley on the end of swage adjust screw213. The pitch of the swage adjust screw 213 is selected to move asliding wedge 212 a small distance. The swage die 274 has acomplementary ramp angle 243 at the opposite end which bears on thewedge 212 to retract or advance the position of the swage die 274 aprecise distance proportional to the movement of the sliding wedge.Thus, the rotation of the swage adjust screw 213 and motion of thesliding wedge 212, results in transverse movement of the swage die 274to thereby finely adjust its fixed position. For example, when a largersuture is to be swaged to a needle, the position of the fixed die 274may be moved further away from the suture drawing axis so as to providethe desired amount of deformation when the swaging pressure is appliedto the needle by the movable swage die 273. In the preferred embodimentshown in FIG. 19, the control system computer 46 will send theappropriate signals to automatically direct the servomotor 214 to adjustthe position of the swage adjust screw 213, and hence, the position ofthe fixed die 274, in accordance with the pull-out test values of theneedle-suture bond as measured by automatic pull-test system asexplained in further detail below.

Specifically, appropriate control signals may be generated to direct theservomotor 214 to adjust the rotational position of the swage adjustscrew 213 in accordance with stored statistical results of thepull-testing occurring at the pull-test station. Automatic pull-testingof the armed needle is desirable to ensure that the upstream swagingdies are optimally positioned to avoid over-swaging the needle-suturebond and hence, preventing the likelihood of clip-off, and, to avoidunder-swaging the needle-suture bond to prevent the chance of pull-out.

Referring to FIG. 22(a), after the needle has been swaged to the suture,the universal gripper 155 closes jaws 146,148 on needle barrel end 44 asthe drive roller 172 is reciprocated out of engagement with plunger 170.Simultaneously therewith, the moveable swage plate 273 is retracted toenable movement of needle 39 by the universal gripper 155. Before theswage dial 110 is rotated, the offset drive cam roller 180(b) is againadvanced to bear against cam plate 186 and provide egress of the needle39 from the swage die cavity in fixed swage plate 274. Once theuniversal gripper 155 and needle 39 have cleared the fixed swage plate,the cam dial assembly 120 is rotated advancing cam rollers 165 inwardlyto retract the universal grippers 155 in a radial direction and enablerotation of the swage dial 110. Swage dial 110 then rotates the needleand suture assembly to a pull test station for testing.

Automatic Pull Test Station

The automatic pull-test station 400 that provides automatic pull-testingof a surgical needle and suture assembly is shown generally in FIGS. 27through 30. As illustrated in FIG. 27 the automatic pull-test assembly400 generally comprises a load cell mounting assembly 430 for mounting aload cell 435 which responds to loading of a V-plate needle arm 436which receives the armed needle 39 from the universal gripper 155. Aneedle release cam roller 172(a) is provided for relaxing the armedneedle from the grip of the universal gripper 155. A pull-test fenceassembly 440 is provided to prevent the armed needle 39 from tippingover or becoming misaligned when the armed needle is relaxed.

The suture gripping assembly 470 includes two pairs of retractablegrippers 425a,b and 426a,b for gripping the suture during thepull-tests. Grippers 425a,b are operatively connected to the weightedslide block assembly 472 for performing non-destructive pull-tests aswill be described with respect to FIGS. 28 and 30. Two separatepneumatic cylinders are used to drive grippers 426a,b for destructivepull-tests.

A detailed description of each of these assemblies and their interactionwill be explained in detail hereinbelow.

As shown in FIG. 27, a surgical needle 39 with attached suture isretained by a universal gripper 155 and, in the manner described above,is indexed to the automatic pull test station 400 by the rotary swagedial 150 to the position illustrated in FIG. 27. To position the armedneedle 39 in the load cell 435, the universal gripper is extended fromthe swage dial 150 from center load "A" to center load "B" so that theend portion 44 of needle 39 is positioned above a correspondingreceiving V-plate arm 436(a) of the load cell assembly 430 as shown inFIG. 27.

FIG. 29(a) illustrates a top view of the load cell assembly 430 withload cell 435 mounted thereon. In the preferred embodiment, load cell435 is loaded by a pivotally mounted V-plate needle arm 436 having athin needle supporting blade 436(a) for supporting the suture receivingend portion 44 of various size surgical needles with the suture material304(b) depending therefrom. Different V-plate arms may be provided fordifferent needle suture combinations which accommodate larger andsmaller sutures having diameters of approximately 0.009 to 0.017+/-0.001inches. Depending upon the batch of surgical needles currently beingpull tested, the appropriate needle V-plate supporting arm 436 will bepositioned to receive the needle from the universal gripper.

Non-destructive pull testing of the armed surgical needle 39 isaccomplished as follows:

After positioning the universal gripper 155 in the extended position asheretofore described, grippers 425a,b of suture gripping assembly 470are closed from an open position to grip the suture strand slightlybelow the needle V-plate supporting arm 436 of load cell assembly 430 asshown in FIG. 20. A single pneumatic actuator 472 (illustrated in FIG.28(a)) is provided for opening and closing gripper arms 425a,b and thecylinder is controlled by a control system program resident in controlsystem computer 46 as explained in further detail in copending patentapplication U.S. Ser. No. 08/804,476 (attorney docket No. 10193)assigned to the same assignee of the present invention, the disclosureof which is incorporated herein by reference thereto.

FIGS. 28(a) and 28(b) illustrate the slide block assembly 472 that iscomposed of slide rods 422a,b and a lower slide block 472a whichreciprocates vertically on the slide rods 422a,b. Slide block 472aincludes a load balancing plate 424 upon which air cylinders 474, 479,apply respective upward and downward forces depending upon the type ofpull-test that is to be performed. As shown in FIG. 27, air cylinder 479is shown in an extended position providing an upward force that supportsthe load balance plate 424 and consequently maintains slide block 472aof slide assembly 472 at a fixed vertical position.

Slide block 472a is counterweighted to a net zero weight byappropriately sized counterweight 476 that is attached to the loadbalance plate at 424(a) and acts through cable 473, around pulley 477,and to attachment point 476a. This counterweight 476 acts to balance thenet load on slide block 472a to a neutral position. An adjustable netdownward force of 2 to 30 oz. is provided by an adjustable springtension device 425, which is more clearly illustrated in FIG. 30. Oneend of spring tension device 425 is mounted to fixed position on theframe 426 by a mounting bolts 427. The other end of spring tensiondevice 425 is attached to the load balancing plate 424 at 424a andexerts an adjustable downward loading between the load balance plate 424and the fixed frame member 426. This adjustable download tension isnormally offset by air motor 479 which drives the lower slide block 424upward to a home position.

The amount of spring tension applied during a non-destructive pull-testcan be varied from 2 to 30 oz. by rotation of knob 428 and the effectivepull test loading is indicated by pointer 429 on scale 430.

To accomplish the non-destructive pull test, air cylinder 479, mountedon sub frame 480 and controlled by system computer 46, is relaxed fromits extended position (FIG. 28(a)) supporting the load balance plate424. This removes the upward force on load balancing plate 424 as shownin FIG. 28(a), to thereby impose the selected spring tension net weightof 2 to 30 ounces downwardly on slide block 472a and through slide rods422a,b to the gripper assembly 470 and the gripper jaws 425a,b to pulldownwardly on the suture attached to swage needle 39, in the directionof arrow "A". The accuracy of this system is enhanced because slideblock 472 is suspended on slide rods 422a,b which are mounted in lowfriction ball bushings, pressed into frame member 471, thereby imposingminimal mechanical drag on the system.

Note in FIG. 27, that the fixed slide block frame 426 is positionedparallel to the axis 444 of the suture depending from the needle 39, andis located a distance away from the axis corresponding to the length ofthe offset arms 420a,b of gripper jaws 425a,b.

Simultaneous with or momentarily before the slide assembly 472 isreleased, the needle release cam roller 172(a) is actuated to enableuniversal gripper 155 to disengage its grip on the armed needle 39.Releasing the armed needle from the grip of the gripper 155 is necessaryto ensure that it is firmly positioned on the V-plate needle supportingblade at 436(a). Moreover, to provide an accurate pull-test, the needlemust be released so that there is no existing upward force that wouldcause false results.

As shown in FIGS. 14 and 27, the needle release cam roller assemblycomprises needle release solenoid 176(a) that is actuated to rotatepivotal lever arm 174. Pivotal lever arm 174 pivots about pin 174(a) todepress plunger 170 of the universal gripper 155 as previously describedwith respect to FIGS. 22(a),(b). As was described with respect to FIG.21(a)-(c), depressing plunger 170 opens jaws 146, 148 to release theneedle 39 engaged therein.

Referring to FIG. 27, to prevent the needle 39 from becoming misalignedor from tipping over after the universal gripper 155 releases its gripon the needle, a needle fence assembly 440 is provided. As shown in FIG.27, the needle fence assembly 440 includes vertical fence plate 442which can be adjusted to lie a needle's diameter away from the face ofgripper 155, and thereby retains the needle in an upright position forthe test. Adjusting the lateral positioning of the vertical fence plate442 is accomplished by rotating lead screws 443 (shown in FIG. 27) toadvance or retract the fence for an appropriate distance. In thepreferred embodiment, the configuration of the face of the verticalneedle fence plate 442 (not shown) may be changed to accommodate theconfigurations of different size needles.

The controlled release of the minimum pull-test is of short duration,preferably ranging in milliseconds. If the test is successful, i.e., thesuture meets the minimum pull-test requirements, the needle isre-gripped by the universal gripper 155 by deactuating the needlerelease solenoid 176(a) which retracts the cam roller 172(a) andreleases the downward force on plunger 170. The suture gripper jaws425a,b are then retracted to their open position to release their gripon the suture as controlled by the control system. Subsequently, theuniversal gripper 155 is retracted and the rotary swage dial 150 androtated to convey the armed needle downstream for bundling.

If the suture fails the minimum pull-test, i.e., if the suture isdislodged from the surgical needle 39 as a result of the non-destructivetest, the control system computer 46 is flagged so that the disarmedneedle 39 will be ejected at the pull-test station. The dislodged suturestrand will be drawn into a vacuum assembly (not shown) and the needle39 will be ejected by a needle stripper assembly 190 shown generally inFIG. 17(a) and in detail in FIG. 24. As shown in FIG. 17(a), needlestripper solenoid 190(a) will be actuated by a control signal outputfrom the control system computer 46 to extend needle stripper pin 192(a)to a space 188 (illustrated in FIG. 21(b) between the needle 39 and theface of the universal gripper 155. Thus, when the needle is in itsrelaxed state on the universal gripper 155 and the minimum pull-testfails, the needle stripper pin 192(a) is extended to remove the needlefrom the universal gripper 155. The needle will fall and be collected byappropriate collection means (not shown) located at the pull-teststation.

After the pull test, whether successful or unsuccessful, the apparatusprepares for the next armed needle to be pull-tested. Slide blockassembly 472 and retracted gripper jaws 325a,b are pushed back up withrespect to the fixed slide mount frame 426 to the home position by anappropriate upward force supplied by the air cylinder 479 as controlledby the control system computer 46. At this time, another data signal maybe sent for storage in a database maintained by the control systemcomputer that indicates that the pull-test performed on the particularneedle 39 was either successful or unsuccessful, together with a datasignal which represents the loading on load cell 435. A signal flag mayalso be sent which indicates that a needle suture assembly is beingconveyed downstream for bundling thereof.

In the preferred embodiment of the invention, the load cell 435,illustrated in FIGS. 27 and 29(a) 29(b) is a piezoelectric transducerthat measures the force applied by the slide block assembly to theneedle-suture assembly 39. The force is received by the needle v-platearm at 436(a), and transmitted to load cell 435 mounted underneath thev-plate arm 436 by virtue of the pivotal mounting of the v-plate needlearm on bolt 438. This single point mount enables an easy parts changefor needle v-plate arm when different needle or suture sizes call for adifferent opening at 436(a). The transducer load cell 435 may beinterfaced with the control system computer 46 by conventional means,and, in the preferred embodiment, is a 25 lb. transducer manufactured byTechniques Co. (Model No. MDB-25PH). The forces applied to the suture 39and measured by the load cell transducer 435 during the destructivepull-testing may be stored for statistical purposes or for real-timemonitoring during a swage die setup routine that may take place when anew batch of surgical needles are to be swaged. For instance, if thenon-destructive pull-tests fail and the force measured by the transducer435 is determined to be at the low end of a predetermined range, thenthe control system computer 46 will acknowledge this and sendappropriate signals to the upstream swaging assembly describedpreviously causing the fixed swaging die 374 to be advanced anincremental amount toward the moveable swage die 373, resulting insubsequent swages being stronger. Likewise, if the non-destructivepull-test passes, i.e., the forces measured by the transducer aredetermined to be between a minimum and maximum load, then no dieadjustment need be made.

As previously mentioned, the automatic pull-test assembly 400 is used toperform a minimum pull-test upon every armed surgical needle indexedthereto prior to automatic packaging thereof. A destructive pull-testingof the armed surgical needle is performed at a parts change set up andat every nth needle indexed thereafter. The purpose of performing adestructive pull-test is to set the swage dies located at the upstreamswaging station for correct maximum swage pull-out value. This is bynecessity a destructive test, and the test frequency, which isprogrammable, is set high enough to maintain control of the operation,but low enough to avoid excessive product waste. In the preferredembodiment, this frequency may be set at every 50th needle, but could beevery 75th or 100th needle.

Another purpose of the destructive pull test is to aid in installing anew swage die set during a changeover procedure, which is a procedurethat is used to prepare the needle swaging apparatus (swage dies) forprocessing a new batch of needles when they are of a different size froma previously processed batch. Contrary to the non-destructive pull-testdescribed above, the pull-test apparatus is programmed for 100%destructive test of a swaged needle, while the swaging assembly isoperating and feeding the armed needles to the pull-test station. Thedie adjustment system at the upstream swaging assembly will receive asignal from the computer 46 transducer load cell 335, at each machinecycle, and quickly perform a correct adjustment of the swage dies.

Destructive test pull-out values are recorded in the system computer 46and are used to compute statistical process control information which isfed back to the machine operator through display screens.

Destructive pull testing of the armed surgical needle 39 is accomplishedsimilarly as described herein above with respect to the minimum pulltest, but with a second pair of gripper jaws 426a,b and destructive testair cylinder 474. However, the fundamental difference between the testsis a fixed mechanical stroke that is always strong enough to pull thesuture out of the needle. This destructive stroke replaces the variable2 to 30 ounce force of the minimum pull test routine.

As shown in FIG. 28(a), a second air cylinder 474 located opposite aircylinder 479 is programmed to provide a fixed stroke against loadbalancing plate 424 from the home position shown in FIG. 28(a). Thisresults in a downward vertical displacement of lower slide blockassembly 472 from the position shown in FIG. 28(a). This also results ina downward force upon slide rods 472(a) and (b), which moves the gripperassembly 470 downwardly, including gripper jaws 426 a,b and the suturegripped therein, in the direction of the arrow "A" as shown in FIG.28(a). The air pressure supplied to cylinder 474 is set high enough toalways pull the suture out of needle 39. This stroke is limited by thebottom portion of slide assembly 472 striking the top of stationaryframe 426. The destructive pull test jaws 426a,b are serrated on theirgripping surface, as shown in FIG. 28(a) to ensure a positive non-slipgrip on the suture during the destruct cycle. Further, the destructgripper jaws 426 a,b are driven by a pair of air cylinders 441,442through angled offset arms 443,444.

The axis of reciprocation for each of the sets of jaws is illustrated inFIG. 28(a), with the axis for the non-destruct gripper at 445, and theaxis of reciprocation for the destructive gripper jaws illustrated inFIG. 28(a) at 446.

The force necessary to accomplish the destructive pull-test is measuredby the piezoelectric load cell transducer 435 as discussed above, anddata representing this force is sent to the control computer 46. If itis determined by the process control algorithm (described below) thatthe destructive pull-test forces as measured by the transducer load cellare lower than a predetermined range of pull-test values, the controlsystem computer 46 will send out appropriate control signals to increasethe swaging die stroke applied when swaging the suture to the needle atthe upstream swaging station. If it is determined that the destructivepull-test forces as measured by the transducer load cell are higher thanthe predetermined range, the control system computer 46 will send outappropriate control signals to the upstream swaging assembly to move afixed swage die a small incremental distance away from the moveableswage jaw, thereby decreasing the swaging pressure applied when swagingthe suture to the needle.

Since the destructive pull-test necessarily results in the suturebecoming dislodged from the needle 39, the needle 39 is again removedfrom the grip of the universal gripper 155 by the needle stripper pin192(a) as described above. Subsequently, the gripper jaws 426a,b areretracted to their open positions and air cylinder 479 provides theupward force to restore the gripping assembly 470 and slide blockassembly 472 back to their normal position in preparation for the nextpull-test.

Off Load Dial Assembly For Needles and Sutures

The offload station 500 is more particularly illustrated and describedwith respect to FIGS. 23 and 25-25(b) in which a plurality of needlebuckets 502 are circumferentially arranged on a rotatable turntable 504to be indexed under the collection point 506 defined by an interceptaxis of a needle stripper 190 and the face of the universal gripper 155.As the needles are stripped from the universal gripper, they fall into aneedle collection bucket which collects the needle inside the bucket,and most of the suture outside the bucket.

One needle stripper assembly 190 is illustrated in FIG. 24, whichstripper includes a reciprocating stripping pin 192, which is springbiased inwardly by spring 193, and reciprocated outwardly by pneumaticmotor 194 to engage the needle to be stripped. The stripping assembliesare secured in position by means of a bracket 191 which is bolted to theframe of the apparatus.

The present invention includes a pair of needle strippers 190a,190b, thelocations of which are illustrated in FIG. 17(a) adjacent thecircumference of the swage dial plate 110. Needle stripper assemblies190(a),(b) are mounted to the frame of the stand alone swage machine bymeans of brackets 191a,191b to provide a longitudinal axis ofreciprocation for the needle stripping pins 192a,b that is tangential tothe circumference described by the face of the universal grippers 155.When the needle stripper pins 192 are retracted, as illustrated in FIG.24, the universal gripper passes the needle stripping station withoutengagement. However, when the needle stripping pins are reciprocatedoutwardly, they intercept the path of needle 39 and are positioned toreciprocate into a space 188 (illustrated in FIGS. 21(b) and 15) definedbetween the face of the universal gripper 155 and the needle 39.Simultaneously therewith, the plunger 170 on the universal gripper isdepressed by one of the offload cams 172 to open the jaws 146,148 of theuniversal gripper and enable the needle to be stripped from theuniversal gripper.

One needle stripper is used at the pull test station to remove needlesthat have failed the suture pull test, and a second is used at the offload station to insure a positive removal of the needle and sutureassembly from the universal gripper at the off load station.

The needle stripper assembly 190(a) illustrated in FIG. 17(a) is used toremove needles that have failed the pull test at the pull test station400. The needle stripper assembly 190(b) is used to remove the needleand suture assembly from the universal gripper for bundling in theoffload station 500.

The needle bucket of the present invention is illustrated in FIGS.25-25(b), wherein FIG. 25 is a side view illustrating the a side view ofthe bucket and the radial reciprocation of the needle bucket, with FIG.25(a) illustrating a front view of the bucket and FIG. 25(b)illustrating a top view of the bucket.

As illustrated in FIG. 25, dotted line axis A illustrates thecircumferential path of the needle in a horizontal plane, while carriedby the universal gripper, while axis B and C illustrate the the radialreciprocation of the universal gripper 155 mounted on the swage dial.The needle stripping pin 192b engages the needle at the intersection ofaxis A and C at intersect 506 causing the needle to drop into the needlebucket 502. The needle falls into the bucket with the suture draped overa comb-like face 520 which holds the suture and assists in preventingentanglement of the sutures when they are removed from the needlebucket. Most of the suture remains outside the bucket, and is capturedwithin a suture shroud 524, illustrated in FIG. 23. The suture shroud524 guides the unsupported end of the suture and prevents entanglementwith the moving parts of the apparatus below the circumferential pathdescribed by the universal gripper. In addition, a stream of deionizedair may be provided at this station to assist in the orderly collectionof the sutures following the swage assembly.

Each of the needle buckets includes a second comb-like surface 522 onone side of the bucket, and an upstanding extended wall portion 526 onthe far side of the collection bucket to assist in capturing any latedropping needles.

Each of the needle buckets 502 is spring mounted for radialreciprocation on turntable 504 by means of a spring loaded reciprocatingmount 508 which nominally biases the needle bucket 502 inwardly. Whenthe needle bucket has arrived at the offload position, the bucket 502 isreciprocated outwardly as illustrated in FIG. 25 by a pneumatic motor510 to the position 502b illustrated in FIG. 25.

FIG. 23 also illustrates a detector 514 which is focused on a reflectorplate 528 under the swage dial assembly 150 that is triggered by apassing suture to actuate the needle stripping assembly 190(b).

After a predetermined number of needle and suture assemblies have beencollected in the needle bucket 502, the needle bucket 502 isreciprocated inwardly by relaxing air motor 510 and the turntable 504 isindexed to position the next available needle bucket 502 under the offload station. While 12 off-load buckets 502 have been illustrated inFIG. 23(a), it is understood that a smaller number of buckets could beused if desired.

After a needle bucket 502 has been filled with a predetermined number ofneedle and suture assemblies, and rotated to the position illustrated at502(c) in FIG. 23, the bundle of needle and suture assemblies may beremoved for subsequent handling and packaging.

As is readily apparent to one skilled in the art, many variations on theabove described embodiment are possible. The foregoing description isexemplary only and not to be construed as limiting the scope of theinvention, which is defined in the claims, as follows.

What is claimed:
 1. A method of attaching a suture to a surgical needlehaving a suture receiving opening formed therein, said methodcomprising:(a) singulating a plurality of randomly arranged surgicalneedles, said method step including the step of manually slidingindividual surgical needles on a surface from said plurality to a dropopening for transfer to an indexing conveyor; (b) roboticallytransferring said surgical needles from said indexing conveyor to aprecise positioning apparatus, and then orienting each surgical needlein a precise position for subsequent automatic handling at a firstpredetermined location; (c) receiving each precisely positioned surgicalneedle at said first predetermined location with a universal gripper andthen indexing each of said surgical needles in said predeterminedorientation from said first predetermined location through successivepredetermined locations for subsequent sequential processing; (d)automatically cutting an indefinite length of suture material to adefinite length at a suture cutting station and automatically insertingsaid suture into said suture receiving opening formed in said surgicalneedle; (e) automatically swaging said surgical needle to close saidsuture receiving opening about a free end of said suture to secure saidsuture thereto and form therefrom a needle and suture assembly; (f)collecting individual needle and suture assemblies from said universalgripper and then forming them into bundles for subsequent packaging;whereby unsorted needles and an indefinite length of suture material areformed into a bundle of needle and suture assemblies.
 2. A method ofattaching a suture to a surgical needle as claimed in claim 1 whereinthe step of receiving each precisely positioned surgical needle with auniversal gripper includes advancing the universal gripper with acompound movement from a first retracted position to a second extendedposition to receive and release each precisely positioned surgicalneedle.
 3. A method of attaching a suture to a surgical needle asclaimed in claim 1, wherein the step of singulating a plurality ofrandomly arranged surgical needles includes the step sliding saidneedles on a sliding surface to said drop opening and depositing each ofsaid singulated needles upon said indexing conveyor means in a spacedapart relation.
 4. A method of attaching a suture to a surgical needleas claimed in claim 3 which further includes the step of positioningsaid insert drop opening above a transfer surface adjacent said indexingconveyor and automatically transferring said individual surgical needlesto said indexing conveyor.
 5. A method of attaching a suture to asurgical needle as claimed in claim 1 which further includes the step ofheating a selected portion of the indefinite length of suture materialto subsequently form a tip for the definite length of suture material.6. A method of attaching a suture to a surgical needle as claimed inclaim 5 wherein said heating step further includes the step oftensioning said indefinite length of suture material as it is heated. 7.A method of attaching a suture to a surgical needle as claimed in claim5 which further includes the step of adjustably positioning a heatingmeans on a moveable carrier remote from said cutting station.
 8. Amethod of attaching a suture to a surgical needle as claimed in claim 5which further includes the step of allowing the selected portion of theindefinite length suture to cool to allow for partial hardening andstiffening of said suture prior to cutting thereof.
 9. A method ofattaching a suture to a surgical needle as claimed in claim 8 whichfurther includes the step of cutting said stiffened selected portion ofthe indefinite length suture strand remote from said heating step tocreate a tipped suture strand of definite length supported by a firstgripping means and a suture strand of indefinite length supported by asecond gripping means, with stiffened portions above each grippingmeans.
 10. A method of attaching a suture to a surgical needle asclaimed in claim 1 wherein said collecting step further includes thestep of receiving said needle and suture assemblies in a plurality ofbuckets.
 11. A method of attaching a suture to a surgical needle asclaimed in claim 10 which further includes the step of stripping saidneedle suture assembly from said universal gripper while incrementallyrotating a plurality of buckets below the stripping point to form saidbundle of needle suture assemblies.
 12. A method of attaching a sutureto a surgical needle as claimed in claim 11 which further includes thestep of rotating said universal gripper means into a confrontingrelationship with said a stripping means, whereby said universal grippermeans deposits an individual oriented needle and suture assembly into apredetermined one of said buckets.